PH - Prisma Health

IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301) (PRISM-MEL-301)

Contact(s):

Lisa Johnson - Lisa.johnson@prismahealth.org

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 18 years and over

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06112314

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Interventions: BIOLOGICAL: IMC-F106C, BIOLOGICAL: Nivolumab, BIOLOGICAL: Nivolumab + Relatlimab

Conditions: Advanced Melanoma

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Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas

Contact(s):

Site Public Contact - Kim.Williams3@prismahealth.org

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 18 years and over

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT02523014

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* Documentation of disease: * Histologic documentation: histologically proven intracranial meningioma as documented by central pathology review * Molecular documentation: Presence of SMO, PTCH1, NF2, CDKN2A, AKT1, PIK3CA, PTEN mutations, CDKN2A copy number loss, CDK4, CDK6, CCND1, CCND2, CCND3, or CCNE1 copy number gain in tumor sample as documented specifically by the central laboratory, regardless of whether prior genotype testing outside of the central laboratory was performed * Progressive OR residual disease, as defined by the following: * Residual measurable disease: residual measurable disease immediately after surgery without requirement for progression; for grade I disease, progression pre-operatively needs to be documented, with an increase in size of the measurable primary lesion on imaging by 25% or more (bidirectional area); the change must occur between scans separated by no more than 25 months; for patients with SMO/PTCH1 mutations enrolling to receive vismodegib, the change can occur between scans separated by up to 25 months; residual measurable disease will be defined by bidimensionally measurable lesions with clearly defined margins by MRI scans, with a minimum diameter of 10 mm in both dimensions * Progressive measurable disease: progression defined as an increase in size of the measurable primary lesion on imaging by 25% or more (bidirectional area); the change must occur between scans separated by no more than 25 months * Post radiation patients: patients with measurable and progressive meningioma who have received radiation are potentially eligible, but need to show evidence of progressive disease after completion of radiation; if the progressive meningioma lesion has been radiated, at least 24 weeks must have elapsed from completion of radiation to registration; if the progressive lesion is outside of the radiation field, then an interval of at least 2 weeks must have elapsed from completion of radiation to registration * Measurable disease: measurable disease is defined by a bidimensionally measurable main lesion on MRI or computed tomography (CT) images (MRI preferred) with clearly defined margins and a minimum diameter of 10 mm in both dimensions; multifocal disease is allowed * Prior treatment * Prior medical therapy is allowed but not required * No limit on number of prior therapies * No chemotherapy, or other investigational agents within 28 days prior to registration * No other concurrent investigational agents or other meningioma-directed therapy (chemotherapy, radiation) while on study; additionally, no cases of nitrosourea or mitomycin C within 6 weeks prior to registration * For patients treated with external beam radiation, interstitial brachytherapy or radiosurgery, an interval \> 4 weeks must have elapsed from completion of radiation therapy to registration; if the progressive lesion is outside of the radiation field, then an interval of at least 2 weeks must have elapsed from completion of radiation to registration * Steroid dosing stable for at least 4 days * Recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or less toxicity from other agents with exception of alopecia and fatigue * No craniotomy 28 days prior to and after registration * Not pregnant and not nursing: \* A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months) * For patients with NF2/CDKN2A/AKT1/PIK3CA/PTEN mutation, CKDN2A copy number loss, or CDK4/CDK6/CCND1/CCND2/CCND3/CCNE1 copy number gain: Age \>= 18 years * For patients with SMO/PTCH1 mutation: Age \>= 30 years * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 * Patient history: * Patients with history of neurofibromatosis (NF) may have other stable central nervous system (CNS) tumors (schwannoma, acoustic neuroma or ependymoma) if lesions have been stable for 6 months * No metastatic meningiomas (as defined by extracranial meningiomas outside of CNS) allowed; spinal meningiomas are allowed * No history of allergic reactions attributed to compounds of similar or biologic composition to assigned study drug * No known active hepatitis B or C * No current Child Pugh class B or C liver disease * No uncontrolled gastric ulcer disease (grade 3 gastric ulcer disease within 28 days of registration) * No uncontrolled hypertension defined as blood pressure (BP) \> 140/90 * No abdominal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within 28 days prior to registration * No major surgery within 28 days prior to registration for any patients with AKT1/PIK3CA/PTEN mutations receiving capivasertib * For patients going on to receive capivasertib (i.e. enrolled after Update #08) * Patients should not have any of the following cardiac criteria: * Any clinically important abnormalities in rhythm, conduction, or morphology of resting electrocardiogram (EKG) (e.g., complete left bundle branch block, third degree heart block) * Any factors that increase the risk of corrected QT (QTc) prolongation or risk of arrhythmic events such as heart failure, hypokalemia, potential for Torsade de Pointes, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age, or any concomitant medication known to prolong the QT interval * Experience any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure New York Heart Association (NYHA) class \>= II * Uncontrolled hypertension (systolic blood pressure \[SBP\] \< 90 mmHg and/or diastolic blood pressure \[DBP\] \< 50 mmHg) * Cardiac ejection fraction outside institutional range of normal or \< 50% (whichever is higher) as measured by echocardiogram (or multigated acquisition \[MUGA\] scan if an echocardiogram can't be performed or is inconclusive); left ventricular ejection fraction (LVEF) below lower limit of normal for site * Patients should not have any of the following criteria: * With the exception of alopecia, any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of registration * Hemoglobin \< 9 g/dL (\< 5.59 mmol/L); note: any blood transfusion must be \>= 14 days prior to the determination of a hemoglobin \>= 9 g/dL (\>= 5.59 mmol/L) * Proteinuria 3+ on dipstick analysis or \> 500 mg/24 hours * Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of capivasertib * History of hypersensitivity to active or inactive excipients of capivasertib or drugs with a similar chemical structure or class to capivasertib * Current disease or condition known to interfere with absorption, distribution, metabolism, or excretion of drugs * Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease * Previous allogeneic bone marrow transplant * Known immunodeficiency syndrome * Concomitant medications (only regarding NF2/CDKN2A/CDK4/CDK6/CCND1/CCND2/CCND3/CCNE1/AKT1/PIK3CA/PTEN genetic alterations): * Chronic concomitant treatment with strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors must discontinue the drug for 14 days prior to registration on the study for patients with NF2 mutation enrolled to GSK2256098, as well as for patients with AKT1/PIK3CA/PTEN mutations enrolled to capivasertib * For NF2 patients going on to receive GSK2256098 and for patients with AKT1/PIK3CA/PTEN mutations enrolled to capivasertib: concomitant treatment with strong CYP3A4 inducers or CYP2D6 substrates is not allowed; patients must discontinue the drug 14 days prior to registration * For NF2 patients going on to receive abemaciclib: avoid concomitant use of CYP3A inducers and strong CYP3A inhibitors; use caution with coadministered moderate or weak CYP3A inhibitors * Diabetic status: * For patients with NF2 or SMO/PTCH1 mutations: No uncontrolled diabetes defined as a known diabetic with HBA1C \> 7.5 OR fasting glucose \> 140 mg/dL. * For patients with AKT1/PIK3CA/PTEN mutations: * Glycosylated hemoglobin (HbA1C) \< 8.0% (63.9 mmol/mol) * No type 1 diabetes mellitus * No requirement for insulin for routine diabetic management and control * No requirement for more than two oral hypoglycemic medications for routine diabetic management and control * Patients with a pre-existing diagnosis of type 2 diabetes mellitus must have fasting glucose \< 9.3 mmol/L (167mg/dL); fasting is defined as no caloric intake for at least 8 hours * Patients without a pre-existing diagnosis of type 2 diabetes mellitus must have fasting glucose =\< 7.0 mmol/L (126 mg/dL); fasting is defined as no caloric intake for at least 8 hours * Absolute neutrophil count (ANC) \>= 1,500/mm\^3 * Platelet count \>= 100,000/mm\^3 * Creatinine OR =\< 1.5 mg/dl x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance \> 50 mL/min * Urine protein:creatinine ratio (UPC) =\< 45 mg/mmol * Total bilirubin =\< 1.5 x upper limit of normal (ULN); except in case of Gilbert's disease * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 x ULN * Sodium, potassium, total calcium (corrected for serum albumin) \& phosphorus within normal limits per institutional guidelines * QTcF \< 450 msec (QT calculated using Fridericia formula) * Mean resting heart rate (determined from EKG) 50-100 beats per minute (BMP) (must be obtained from 12-lead EKG defined by a triplicate EKG for patients assigned to the capivasertib arm; patients assigned to all other arms will require a single EKG * No uncontrolled medical comorbidities per investigator discretion (e.g. interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or pre-existing Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea) * ADDITIONAL REGISTRATION ELIGIBILITY CRITERIA FOR ABEMACICLIB ARM: Hemoglobin \>= 8 g/dL \* Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator; initial treatment must not begin earlier than the day after the erythrocyte transfusion * ADDITIONAL REGISTRATION ELIGIBILITY CRITERIA FOR ABEMACICLIB ARM: Prior Treatment * Patients who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events \[CTCAE\] grade =\< 1) from the acute effects of chemotherapy except for residual alopecia or grade 2 peripheral neuropathy prior to registration; a washout period of at least 28 days is required between last chemotherapy dose and registration (provided the patient did not receive radiotherapy) * Patients who received adjuvant radiotherapy must have completed and fully recovered from the acute effects of radiotherapy; a washout period of at least 28 days is required between end of radiotherapy and registration * ADDITIONAL REGISTRATION ELIGIBILITY CRITERIA FOR ABEMACICLIB ARM: No active bacterial infection (requiring intravenous \[IV\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \[for example, hepatitis B surface antigen positive\]); screening is not required for enrollment in the absence of symptoms * ADDITIONAL REGISTRATION ELIGIBILITY CRITERIA FOR ABEMACICLIB ARM: No personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest

Interventions: DRUG: Vismodegib, DRUG: FAK Inhibitor GSK2256098, DRUG: Capivasertib, DRUG: Abemaciclib

Conditions: Intracranial Meningioma, Recurrent Meningioma, NF2 Gene Mutation

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National Cancer Institute "Cancer Moonshot Biobank"

Contact(s):

IRB@prismahealth.org

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 13 years and over

Phase:

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT04314401

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Inclusion Criteria:

* Is consistent with OR has been diagnosed with one of the following: * Colorectal cancer: Stage IV * Non-small cell or small cell lung cancer: stage III/IV * Prostate cancer: metastatic prostate cancer * Gastric cancer, not otherwise specified (NOS): stage IV * Esophageal cancer, NOS: stage IV * Adenocarcinoma of gastroesophageal junction: stage IV * High grade serous ovarian cancer: stage III/IV * Invasive breast carcinoma: stage III/IV * Melanoma: stage III/IV * Acute myeloid leukemia * Multiple myeloma * For the purposes of this study, re-staging is allowed * Patient should fit in one of the following four clinical scenarios (a-d) * Undergoing diagnostic workup for one of the diseases listed for which treatment will likely include a new regimen of standard of care therapy OR * Scheduled to begin treatment with a new regimen of standard of care therapy OR * Currently progressing on a regimen of standard of care therapy OR * Currently being treated with a regimen standard of care therapy, without evidence of progression * Requirements for fresh tissue biospecimen collections at enrollment: * For clinical scenarios a, b, and c above, freshly collected tumor tissue or bone marrow (BM) aspirate must be submitted at enrollment * For clinical scenarios a and b, the fresh tissue collection must be prior to starting therapy * For clinical scenario a, the biospecimen collection must be part of a standard of care medical procedure * For clinical scenarios b or c, the biospecimen collection may be part of a standard of care medical procedure OR * The biospecimen collection may be part of a study-specific procedure ("research only biopsy"), when the patient has a tumor amenable to image guided or direct vision biopsy and is willing and able to undergo a tumor biopsy for molecular profiling * Note: For research-only biopsies, the biopsy must not be associated with a significant risk of severe or major complications or death; the procedure cannot be a mediastinal, laparoscopic, open or endoscopic biopsy; nor can the procedure be a brain biopsy; nor can the patient be under the age of majority as determined by each U.S. state * Requirements for archival tissue: * For clinical scenarios a and b above, archival tissue as outlined below must be submitted IF AVAILABLE * For clinical scenarios c and d above, archival tissue as outlined below is REQUIRED * Pre-existing archival material (formalin-fixed, paraffin-embedded \[FFPE\] block, BM aspirate, or unstained slides) that: * Contains the cancer type for which the participant is enrolled, and * Was collected no more than 5 years prior to initiation of therapy, and * Contains at least a surface area of 5 mm\^2 and optimum surface area of 25 mm\^2 or 3-5 mL cryopreserved bone marrow aspirate to yield 200 million bone marrow mononuclear cells, and * No more than 1 line of standard of care systemic therapy was administered from the date of archival material collection to the date of initiation of therapy * Requirements for blood collection: ALL scenarios require fresh blood collection at enrollment * Blood collection for clinical scenarios a, b, and c must take place within 1 week of fresh tumor specimen collection * Blood collection for clinical scenario d must take place within 4 weeks of enrollment * Age 13 or older * Any sex and any gender * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2 * Ability to understand and willingness to sign an informed consent document. Consent may be provided by a Legally Authorized Representative (LAR) in accordance with 45 CFR 46.102(i)

Exclusion Criteria:

* Treated with or has already begun treatment with a non-standard of care therapeutic agent (investigational) in an interventional clinical trial * Uncontrolled intercurrent illness that in the physician's assessment would pose undue risk for biopsy * Use of full dose coumarin-derivative anticoagulants such as warfarin are prohibited. Patients may be switched to low molecular weight (LMW) heparin at physician discretion * Low molecular weight (LMW) heparin is permitted for prophylactic or therapeutic use * Factor X inhibitors are permitted * Use of anti-platelet drugs are permitted * Stopping the anticoagulation treatment for biopsy, bone marrow aspirate, or resection should be per site standard operating procedure (SOP) * NCI PDMR EXCLUSION CRITERIA: Patients with CRC that is not mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) * NCI PDMR EXCLUSION CRITERIA: Patients with complete response * NCI PDMR EXCLUSION CRITERIA: Patients with invasive fungal infections * NCI PDMR EXCLUSION CRITERIA: Patients with active and/or uncontrolled infections or who are still recovering from an infection * Actively febrile patients with uncertain etiology of febrile episode * All antibiotics for non-prophylactic treatment of infection should be completed at least 1 week (7 days) prior to collection * No recurrence of fever or other symptoms related to infection for at least 1 week (7 days) following completion of antibiotics * NCI PDMR EXCLUSION CRITERIA: Patients with human immunodeficiency virus (HIV), active or chronic hepatitis (i.e. quantifiable hepatitis B virus \[HBV\]-deoxyribonucleic acid \[DNA\] and/or positive hepatitis B surface antigen \[HbsAg\], quantifiable hepatitis C virus \[HCV\]-ribonucleic acid \[RNA\]) or known history of HBV/HCV without documented resolution

Interventions: PROCEDURE: Biospecimen Collection, OTHER: Medical Chart Review

Conditions: Malignant Solid Neoplasm, Stage IV Ovarian Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8, Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Clinical Stage IV Esophageal Adenocarcinoma AJCC v8, Clinical Stage IV Esophageal Squamous Cell Carcinoma AJCC v8, Clinical Stage IV Gastric Cancer AJCC v8, Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8, Lung Small Cell Carcinoma, Metastatic Prostate Carcinoma, Stage III Lung Cancer AJCC v8, Stage III Ovarian Cancer AJCC v8, Stage IV Colorectal Cancer AJCC v8, Stage IV Lung Cancer AJCC v8, Acute Myeloid Leukemia, Multiple Myeloma, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Lung Non-Small Cell Carcinoma

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Comparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis (CAPTIVA)

Contact(s):

Phil Fleming - Phil.Fleming2@prismahealth.org

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 30 years and over

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT05047172

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Inclusion Criteria:

* Acute focal symptoms or signs of any duration associated with imaging, pathological, or other objective evidence of arterial infarction OR clinical evidence of cerebral, spinal cord, or retinal focal arterial ischemic injury based on symptoms persisting greater than or equal to 24 hours that occurred within 30 days prior to randomization * Index stroke is attributed to 70-99% stenosis (or flow gap on MRA) of a major intracranial artery (carotid artery, middle cerebral artery (M1 or M2), vertebral artery (V4), basilar artery, posterior cerebral artery (P1), or anterior cerebral artery (A1)) documented by CTA, MRA, or catheter angiography * Modified Rankin Scale score of ≤ 4, at time of consent * Ability to swallow pills * At least 30 years of age, inclusive, at time of consent * Subjects 30-49 years of age are required to meet at least ONE of the following additional criteria below to qualify for the study:
• diabetes treated with insulin for at least 15 years
• at least 2 of the following atherosclerotic risk factors: hypertension (BP \> 140/90 or on antihypertensive therapy); dyslipidemia (LDL \> 130 mg /dl or HDL \< 40 mg/dl or fasting triglycerides \> 150 mg/dl or on lipid lowering therapy); smoking; non-insulin dependent diabetes or insulin dependent diabetes of less than 15 years duration; any of the following vascular events occurring in a parent or sibling who was \< 55 years of age for men or \< 65 years of age for women at the time of the event: myocardial infarction, coronary artery bypass, coronary angioplasty or stenting, stroke, carotid endarterectomy or stenting, peripheral vascular surgery for atherosclerotic disease
• personal history of any of the following: myocardial infarction, coronary artery bypass, coronary angioplasty or stenting, carotid endarterectomy or stenting, or peripheral vascular surgery for atherosclerotic disease
• any stenosis of an extracranial carotid or vertebral artery, another intracranial artery, subclavian artery, coronary artery, iliac or femoral artery, other lower or upper extremity artery, mesenteric artery, or renal artery that was documented by non-invasive vascular imaging or catheter angiography and is considered atherosclerotic
• aortic arch atheroma documented by non-invasive vascular imaging or catheter angiography
• any aortic aneurysm documented by non-invasive vascular imaging or catheter angiography that is considered atherosclerotic * Negative pregnancy test in a female who has had any menses in the last 18 months and has not had surgery that would make her unable to become pregnant * Subject is willing and able to return for all follow-up evaluations required by the protocol * Subject is available by phone * Subject understands the purpose and requirements of the study and can make him/herself understood * Subject has provided informed consent (use of a LAR is not permitted)

Exclusion Criteria:

* Previous treatment of qualifying intracranial artery with a stent, angioplasty, or other mechanical device, including mechanical thrombectomy for the qualifying stroke, or plan to perform one of these procedures * Plan to perform concomitant endarterectomy, angioplasty or stenting of an extracranial vessel tandem to the symptomatic intracranial stenosis * Intracranial tumor (except meningioma) or any intracranial vascular malformation * Thrombolytic therapy within 24 hours prior to randomization * Progressive neurological signs within 24 hours prior to randomization * History of spontaneous non-traumatic intracranial hemorrhage (parenchymal, subarachnoid, subdural, epidural) * Intracranial arterial stenosis due to: arterial dissection; MoyaMoya disease; any known vasculitic disease; herpes zoster, varicella zoster or other viral vasculopathy; neurosyphilis; any other intracranial infection; any intracranial stenosis associated with CSF pleocytosis; radiation induced vasculopathy; fibromuscular dysplasia; sickle cell disease; neurofibromatosis; benign angiopathy of central nervous system; postpartum angiopathy; suspected vasospastic process; reversible cerebral vasoconstriction syndrome (RCVS); suspected recanalized embolus * Presence of any of the following unequivocal cardiac sources of embolism: chronic or paroxysmal atrial fibrillation, mitral stenosis, mechanical valve, endocarditis, intracardiac clot or vegetation, myocardial infarction within three months, left atrial spontaneous echo contrast * Known allergy or contraindication to aspirin, rivaroxaban, clopidogrel, or ticagrelor * Uncontrolled severe hypertension (systolic pressure \> 180 mm Hg or diastolic pressure \> 115 mm Hg), active peptic ulcer disease, major systemic hemorrhage within 30 days prior to randomization, active bleed or bleeding diathesis, platelets \< 100,000, hematocrit \< 30, INR \> 1.5, clotting factor abnormality that increases the risk of bleeding, current alcohol or substance abuse, severe liver impairment (AST or ALT \> 3 x normal, cirrhosis), or CrCl \< 15 mL/min or on dialysis * Major surgery (including stenting of any vessel; open femoral, aortic, or carotid surgery; or cardiac surgery) within previous 30 days prior to randomization or planned in the next 90 days after randomization * Any condition other than intracranial arterial stenosis that requires the subject to take any antithrombotic medication other than aspirin (NOTE: exceptions allowed for subcutaneous heparin or enoxaparin for deep vein thrombosis (DVT) prophylaxis) * Dementia or psychiatric problem that prevents the subject from following an outpatient program reliably * Co-morbid conditions that may limit survival to less than 12 months * Pregnancy or of childbearing potential and unwilling to use contraception for the duration of this study, or currently breastfeeding * Current or anticipated concomitant oral or intravenous therapy with strong CYP3A4 inhibitors or CYP3A4 substrates that cannot be stopped for the course of this study * Enrollment in another study that would conflict with the current study

Interventions: DRUG: Ticagrelor + Aspirin, DRUG: Rivaroxaban + Aspirin, DRUG: Clopidogrel + Aspirin, OTHER: Risk Factor Management

Conditions: Intracranial Arteriosclerosis, Stroke

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Ramucirumab and Paclitaxel or FOLFIRI in Advanced Small Bowel Cancers

Contact(s):

Christy Klepetko - cklepetko@swog.org

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 18 years and over

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT04205968

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Inclusion Criteria:

* Patients must have histologically or cytologically confirmed small bowel adenocarcinoma. Ampullary adenocarcinomas are not eligible. Patients must have metastatic disease or locally advanced unresectable disease * Brain metastases are allowed if they have been adequately treated with radiotherapy or surgery and stable for at least 30 days prior to registration. Patients must be neurologically asymptomatic and without corticosteroid treatment for at least 7 days prior to registration * Patients must have measurable or non-measurable disease. All scans needed for assessment of measurable disease must be performed within 28 days prior to registration. Non-measurable disease must be assessed within 42 days prior to registration. All disease must be assessed and documented on the Baseline Tumor Assessment Form * Patients must have progressed on prior therapy with a fluoropyrimidine and/or oxaliplatin, given either for metastatic/locally advanced disease or as adjuvant therapy completed within the previous 12 months * Patients must have completed prior chemotherapy, immunotherapy, or radiation therapy at least 14 days prior to registration and all toxicity must be resolved to grade 1 (with the exception of grade 2 neuropathy) prior to registration. In Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 2 sensory neuropathy is defined as "moderate symptoms; limiting instrumental activities of daily living (ADLs)" * Patients must have a complete medical history and physical exam within 28 days prior to registration * Patients must have a Zubrod performance status of 0 or 1 * Absolute neutrophil count (ANC) \>= 1,500/mcL (must be obtained within 28 days prior to registration) * Platelets \>= 100,000/mcL (must be obtained within 28 days prior to registration) * A total bilirubin =\< 1.5 x institutional limit normal (IULN) (must be obtained within 28 days prior to registration) * Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 3.0 x IULN (or 5.0 x IULN if liver metastases are present) (must be obtained within 28 days prior to registration) * Serum creatinine =\< 1.5 x IULN OR calculated creatinine clearance \>= 40 mL/min (must have been obtained within 28 days prior to registration) * Patient must have urinary protein =\< 1+ on dipstick or routine urinalysis (UA) within 28 days prior to registration. If dipstick or routine analysis is \>= 2+, a 24 - hour urine collections for protein must demonstrate \< 1000 mg of protein in 24 hours * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial * Patients must not have known dihydropyrimidine dehydrogenase deficiency * Patients must be offered the opportunity to participate in specimen banking * Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines

Exclusion Criteria:

* Patients must not have received prior treatment with irinotecan, taxane, or ramucirumab for small bowel adenocarcinoma * Patients must not have had major surgery within 28 days prior to registration, or minor surgery within 7 days prior to registration, and must not be planned for elective major surgery to be performed during protocol treatment * Patients must not be currently enrolled in or have discontinued within the last 28 days a clinical trial involving an investigational product or non-approved use of a drug, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. Patients participating in surveys or observational studies are eligible to participate in this study * Patients must not be receiving chronic antiplatelet therapy, including dipyridamole or clopidogrel, or similar agents * Patient must not have a known bleeding diathesis * Patient must not have uncontrolled or poorly-controlled hypertension (\> 160 mmHg systolic or \> 100 mg HG diastolic for \> 4 weeks) despite standard medical management * Patient tumors must not have known deficient mismatch repair (dMMR) or microsatellite instability high (MSI-H) * Patients must not be pregnant or nursing and must have had a negative pregnancy test within 4 weeks of starting treatment. Women/men of reproductive potential must have agreed to use an effective contraceptive method. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures * Patients must not have an active infection requiring systemic therapy * Patient must not have liver dysfunctions manifested by either (1) Child-Pugh B (or worse) or (2) cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis * Patients must not have a history of deep vein thrombosis (DVT), pulmonary embolism (PE), or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered "significant") during the 90 days prior to registration * Patients must not have experienced any arterial thrombotic event (including but not limited to myocardial infarction, unstable angina, stable angina markedly limiting ordinary physical activity, cerebrovascular accident, or transient ischemic attack) within 120 days prior to registration * Patients must not have a prior history of gastrointestinal (GI) perforation/fistula or other risk factors for perforation within 120 days prior to registration * Patients must not have experienced any grade 3-4 GI bleeding within 90 days prior to registration * Patient must not have experienced any serious or non-healing wound, ulcer, or bone fracture within 28 days prior to registration

Interventions: DRUG: Fluorouracil, DRUG: Irinotecan, DRUG: Irinotecan Hydrochloride, DRUG: Leucovorin, DRUG: Leucovorin Calcium, DRUG: Paclitaxel, BIOLOGICAL: Ramucirumab

Conditions: Metastatic Small Intestinal Adenocarcinoma, Stage III Small Intestinal Adenocarcinoma AJCC v8, Stage IIIA Small Intestinal Adenocarcinoma AJCC v8, Stage IIIB Small Intestinal Adenocarcinoma AJCC v8, Stage IV Small Intestinal Adenocarcinoma AJCC v8

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GORE® ENFORM Biomaterial Product Study (ENF 18-06)

Contact(s):

Abby Birrell - abby.birrell@prismahealth.org

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 18 years and over

Phase: NA

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT04718168

Show full eligibility criteria

Pre-procedure

Inclusion Criteria:

The subject is / has:
• At least 18 years old at the time of informed consent. Minimum age required by state regulations (as applicable).
• An expected scored Class I (Clean) surgical wound using CDC Surgical Wound Classification system.
• A planned implant with GORE® ENFORM Biomaterial for a single site ventral or hiatal hernia repair as suture line reinforcement.
• An expected scored Grade 1 or Grade 2 using the Ventral Hernia Working Group Grading system.
• Willing to provide informed consent and comply with follow-up requirements. Pre-procedure

Exclusion Criteria:

The subject is / has:
• Treated in another drug or medical device study within 1 year of study enrollment.
• Implanted with GORE® ENFORM Biomaterial in the reconstruction of cardiovascular defects.
• Hernia repair expected to be performed as part of a bridged procedure (i.e., expected inability to perform primary closure of fascia or crura, patients requiring permanent support from the device).
• A BMI \>40.
• Evidence of a systemic infection.
• Cirrhosis or undergoing dialysis.
• A wound-healing disorder.
• Immunocompromised such as, with HIV or transplant, or receiving chemo or radiation therapy.
• Expected to undergo mesh implantation in conjunction with any bariatric procedure and / or panniculectomy procedure.
• A stoma.
• Co-morbid conditions that may limit their ability to comply with study and follow-up requirements.
• Positive pregnancy or lactation status as confirmed by site standard of care.
• Hernias requiring treatment within multiple body regions or expected use of multiple hernia mesh devices. Post-procedure Inclusion Criteria At the time of index procedure, the subject is / has:
• At least 18 years old. Minimum age required by state regulations (as applicable).
• Implanted with GORE® ENFORM Biomaterial for a single site ventral or hiatal hernia repair as suture-line reinforcement on or before 365 days prior to site protocol amendment 3 approval date.
• Unless there is an Informed Consent waiver issued by the Institutional Review Board (IRB), an Informed Consent Form (ICF) signed by subject. Post-procedure Exclusion Criteria At the time of index procedure, the subject is / has:
• Treated in another drug or medical device study within 1 year of study enrollment.
• Implanted with GORE® ENFORM Biomaterial in the reconstruction of cardiovascular defects.
• Hernia repair that was performed as part of a bridged procedure (i.e., inability to perform primary closure of fascia or crura, patients requiring permanent support from the device).
• A BMI \>40.
• Evidence of a systemic infection.
• Cirrhosis or undergoing dialysis.
• A wound-healing disorder.
• Immunocompromised such as, with HIV or transplant, or receiving chemo or radiation therapy.
• Underwent mesh implantation in conjunction with any bariatric procedure and / or panniculectomy procedure.
• A stoma.
• Co-morbid conditions that may limit their ability to comply with study and follow-up requirements.
• Positive pregnancy or lactation status as confirmed by site standard of care.
• Hernias requiring treatment within multiple body regions or expected use of multiple hernia mesh devices.

Interventions: DEVICE: Gore ENFORM Biomaterial (Preperitoneal), DEVICE: Gore ENFORM Biomaterial (Intraperitoneal)

Conditions: Hernia, Ventral, Hernia, Hiatal, Hernia, Diaphragmatic, Incisional Hernia

Keywords: hernia, ventral, hiatal, diaphragmatic, incisional, mesh, Gore, W.L. Gore, Enform

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Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve Decongestion Management System (DMS) (FASTR)

Contact(s):

Annemarie Forrest - aforrest@reprievecardio.com

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 18 years and over

Phase: NA

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT05174312

Show full eligibility criteria

Interventions: DEVICE: Reprieve Decongestion Management System, DRUG: Diuretic

Conditions: Acute Decompensated Heart Failure

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A Study to Evaluate Adverse Events of Subcutaneous (SC) Epcoritamab Administered in the Outpatient Setting in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Classic Follicular Lymphoma

Contact(s):

ABBVIE CALL CENTER - abbvieclinicaltrials@abbvie.com

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 18 years and over

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT05451810

Show full eligibility criteria

Interventions: DRUG: Epcoritamab

Conditions: Diffuse Large B-Cell Lymphoma, Classic Follicular Lymphoma

Keywords: Relapsed or Refractory Diffuse Large B-Cell Lymphoma, Relapsed or Refractory Classic Follicular Lymphoma, Non-Hodgkins Lymphoma, Cancer, Epcoritamab, ABBV-GMAB-3013, EPCORE

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A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab

Contact(s):

IRB@prismahealth.org

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 5 years to 60 years old

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT05675410

Show full eligibility criteria

Inclusion Criteria:

* Patients must be 5 to 60 years of age at the time of enrollment * Patients with newly diagnosed untreated histologically confirmed classic Hodgkin lymphoma (cHL) (nodular sclerosis, mixed cellularity, lymphocyte-rich, or lymphocyte-depleted, or not otherwise specified \[NOS\]) with stage I or II disease * Patients must have bidimensionally measurable disease (at least one lesion with longest diameter \>= 1.5 cm) * Patients must have a whole body or limited whole body PET scan performed within 42 days prior to enrollment. PET-CT is strongly preferred. PET-MRI allowed if intravenous contrast enhanced CT is also obtained * Pediatric patients (age 5-17 years) must have an upright posteroanterior (PA) chest X-ray (CXR) for assessment of bulky mediastinal disease. Adult patients must have either a CXR or CT chest * Patients \>= 18 years must have a performance status corresponding to Zubrod scores of 0, 1 or 2 * Patients =\< 17 years of age must have a Lansky performance score of \>= 50 * Pediatric patients (age 5-17 years): A serum creatinine based on age/gender as follows (within 7 days prior to enrollment): * 2 to \< 6 years (age): 0.8 mg/dL (male), 0.8 mg/dL (female) * 6 to \< 10 years (age): 1 mg/dL (male), 1 mg/dL (female) * 10 to \< 13 years (age): 1.2 mg/dL (male), 1.2 mg/dL (female) * 13 to \< 16 years (age): 1.5 mg/dL (male), 1.4 mg/dL (female) * \>= 16 years (age): 1.7 mg/dL (male), 1.4 mg/dL (female) OR a 24 hour urine creatinine clearance \>= 50 mL/min/1.73 m\^2 (within 7 days prior to enrollment) OR a glomerular filtration rate (GFR) \>= 50 mL/min/1.73 m\^2 (within 7 days prior to enrollment). GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard) * Note: Estimated GFR (eGFR) from serum or plasma creatinine, cystatin C or other estimates are not acceptable for determining eligibility * For adult patients (age 18 years or older) (within 7 days prior to enrollment): Creatinine clearance \>= 30 mL/min, as estimated by the Cockcroft and Gault formula or a 24-hour urine collection. The creatinine value used in the calculation must have been obtained within 28 days prior to registration. Estimated creatinine clearance is based on actual body weight * Total bilirubin =\< 2 x upper limit of normal (ULN) (within 7 days prior to enrollment) * Unless due to Gilbert's disease, lymphomatous involvement of liver or vanishing bile duct syndrome * Aspartate aminotransferase (AST) =\< 3 x ULN (within 7 days prior to enrollment) * Unless due to Gilbert's disease, lymphomatous involvement of liver or vanishing bile duct syndrome * Alanine aminotransferase (ALT) =\< 3 x ULN (within 7 days prior to enrollment) * Unless due to Gilbert's disease, lymphomatous involvement of liver or vanishing bile duct syndrome * Shortening fraction of \>= 27% by echocardiogram (ECHO), multigated acquisition scan (MUGA), or functional cardiac imaging scan (within 7 days prior to enrollment) or ejection fraction of \>= 50% by radionuclide angiogram, ECHO, MUGA, or cardiac imaging scan (within 7 days prior to enrollment) * Diffusion capacity of the lung for carbon monoxide (DLCO) \>= 50% of predicted value as corrected for hemoglobin by pulmonary function test (PFT) (within 7 days prior to enrollment). If unable to obtain PFTs, the criterion is: a pulse oximetry reading of \> 92% on room air * Known human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load

Exclusion Criteria:

* Patients with nodular lymphocyte predominant Hodgkin lymphoma * Patients with a history of active interstitial pneumonitis or interstitial lung disease * Patients with a diagnosis of inherited or acquired immunodeficiency that is poorly controlled or requiring active medications, such as primary immunodeficiency syndromes or organ transplant recipients * Patients with any known uncontrolled intercurrent illness that would jeopardize the patient's safety such as infection, autoimmune conditions, cardiac arrhythmias, angina pectoris, and gastrointestinal disorders affecting swallowing and/or absorption of pills * Patients with a condition requiring systemic treatment with either corticosteroids (defined as equivalent to \> 10 mg daily prednisone for patients \>= 18 years or \> 0.5 mg/kg \[up to 10 mg/day\] for patients \< 18 years) or other immunosuppressive medications within 14 days prior to enrollment * Note: Replacement therapy such as thyroxine, insulin, or physiologic corticosteroid for adrenal or pituitary insufficiency is not considered a form of systemic treatment. Inhaled or topical steroids, and adrenal replacement doses (=\< 10 mg daily for patients \>= 18 years or =\< 0.5 mg/kg \[up to 10 mg/day\] prednisone equivalents) are permitted in the absence of active autoimmune disease * Note: Steroid use for the control of Hodgkin lymphoma symptoms is allowable, but must be discontinued by cycle 1, day 1 * Patients with peripheral neuropathy \> grade 1 at the time of enrollment or patients with known Charcot-Marie-Tooth syndrome * Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen * Administration of prior chemotherapy, radiation, or antibody-based treatment for cHL * Prior solid organ transplant * Prior allogeneic stem cell transplantation * Live vaccine within 30 days prior to planned day 1 of protocol therapy (e.g., measles, mumps, rubella, varicella, yellow fever, rabies, bacillus calmette guerin \[BCG\], oral polio vaccine, and oral typhoid). Administration of messenger ribonucleic acid (mRNA) vaccines are permitted * Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test within 28 days prior to enrollment is required for female patients of childbearing potential * Lactating females who plan to breastfeed their infants starting with the first dose of study therapy and for at least 6 months after the last treatment * Sexually active patients of reproductive potential who have not agreed to use a highly effective contraceptive method (failure rate of \< 1% per year when used consistently and correctly) for the duration of their study drug therapy. Following therapy, patients will be advised to use contraception as per institutional practice or as listed below for investigational agents, whichever is longer * Men and women of childbearing potential must continue contraception for a period of 6 months after last dose of brentuximab vedotin * Women of child-bearing potential (WOCBP) must continue contraception for a period of at least 5 months after the last dose of nivolumab * All patients and/or their parents or legal guardians must sign a written informed consent * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Interventions: PROCEDURE: Biospecimen Collection, BIOLOGICAL: Bleomycin Sulfate, DRUG: Brentuximab Vedotin, PROCEDURE: Computed Tomography, DRUG: Cyclophosphamide, DRUG: Dacarbazine, DRUG: Doxorubicin Hydrochloride, DRUG: Etoposide, DRUG: Etoposide Phosphate, OTHER: Fludeoxyglucose F-18, RADIATION: Involved-site Radiation Therapy, PROCEDURE: Magnetic Resonance Imaging, BIOLOGICAL: Nivolumab, PROCEDURE: Positron Emission Tomography, DRUG: Prednisolone, DRUG: Prednisone, DRUG: Procarbazine Hydrochloride, OTHER: Questionnaire Administration, DRUG: Vinblastine Sulfate, DRUG: Vincristine Sulfate

Conditions: Lugano Classification Limited Stage Hodgkin Lymphoma AJCC v8

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Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Select Advanced Solid Tumor Indications Receiving Intravenous (IV) ABBV-400

Contact(s):

ABBVIE CALL CENTER - abbvieclinicaltrials@abbvie.com

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 18 years and over

Phase: PHASE1

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06084481

Show full eligibility criteria

Inclusion Criteria:

* Laboratory values meeting the criteria laid out in the protocol. * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. * Documented diagnosis of locally advanced or metastatic hepatocellular carcinoma (HCC), pancreatic ductal adenocarcinoma (PDAC), biliary tract cancers (BTC), squamous cell carcinoma of the esophagus, (ESCC), triple negative breast cancer (TNBC), hormone receptor+/HER2-breast cancer (HR+/HER2-BC), head and neck squamous-cell-carcinoma (HNSCC), or Platinum Resistant High Grade Epithelial Ovarian Cancer (PROC)/primary peritoneal/fallopian tube cancer (by World Health Organization \[WHO\] criteria). Participant meets the criteria for disease activity laid out in the protocol.

Exclusion Criteria:

* Have received anticancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within 28 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of ABBV-400. Palliative radiation therapy for bone, skin, or subcutaneous metastases with 10 fractions or less is permitted and not subject to a washout period. * Unresolved clinically significant AEs \> Grade 1 from prior anticancer therapy. * History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD or pneumonitis, including but not limited to those listed in the protocol. * History of clinically significant, intercurrent lung-specific illnesses, including those laid out in the protocol. * Untreated brain or meningeal metastases (i.e., participants with history of metastases are eligible provided they do not require ongoing steroid treatment for cerebral edema and have shown clinical and radiographic stability for at least 14 days after definitive therapy). Participants may continue on antiepileptic therapy if required. * History of other active malignancy, with the exception of those laid out in the protocol. * Any autoimmune, connective tissue or inflammatory disorders with documented or suspicious pulmonary involvement at screening (i.e., rheumatoid arthritis, Sjogren's, sarcoidosis etc.), and prior pneumonectomy.

Interventions: DRUG: ABBV-400

Conditions: Hepatocellular Carcinoma, Pancreatic Ductal Adenocarcinoma, Biliary Tract Cancers, Esophageal Squamous Cell Carcinoma, Triple Negative Breast Cancer, Hormone Receptor+/Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer, Head and Neck Squamous-Cell Carcinoma, Platinum Resistant High Grade Epithelial Ovarian Cancer

Keywords: Hepatocellular Carcinoma, Pancreatic Ductal Adenocarcinoma, Biliary Tract Cancers, Esophageal Squamous Cell Carcinoma, Triple Negative Breast Cancer, Hormone Receptor+/Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer, Head and Neck Squamous-Cell Carcinoma, Platinum Resistant High Grade Epithelial Ovarian Cancer, Solid Tumors, Advanced Solid Tumors, ABBV-400

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A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT

Contact(s):

IRB@prismahealth.org

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 3 years to 29 years old

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT04684368

Show full eligibility criteria

Inclusion Criteria:

* Patients must be \>= 3 years and \< 30 years at the time of study enrollment * Patients must be newly diagnosed with localized primary CNS NGGCT of the suprasellar and/or pineal region by pathology and/or serum or cerebrospinal fluid (CSF) elevation of AFP above institutional normal or \> 10 ng/mL or human chorionic gonadotropin (hCG) beta \> 100 mIU/mL as confirmed by Rapid Central Marker Screening Review on APEC14B1-CNS. Suprasellar, pineal and bifocal tumors are included. (CSF tumor markers and cytology must be within 31 days prior to enrollment and start of protocol therapy \[repeat if necessary\]. Serum tumor markers, AFP and hCGbeta must be within 7 days prior to enrollment and start of protocol therapy \[repeat if necessary\]). Basal ganglia or other primary sites are excluded * Patients with any of the following pathological elements are eligible: endodermal sinus (yolk sac), embryonal carcinoma, choriocarcinoma, malignant/immature teratoma and mixed germ cell tumor (GCT) (i.e., may include some pure germinoma) if malignant elements listed above are present. Patients with only mature teratoma are excluded. Patients with pure germinoma admixed with mature teratoma are excluded (would be eligible for pure germinoma protocols) * Patients must have a cranial MRI with and without gadolinium at diagnosis/prior to enrollment. If surgical resection is performed, patients must have pre-operative and post operative brain MRI with and without gadolinium. The post operative brain MRI should be obtained within 72 hours of surgery. If patient has a biopsy only, post-operative brain MRI is recommended but not required (within 31 days prior to study enrollment and start of protocol therapy ) * Patients must have a spine MRI with gadolinium obtained at diagnosis/prior to enrollment. Spine MRI with and without gadolinium is recommended (within 31 days prior to study enrollment and start of protocol therapy) * Lumbar CSF must be obtained prior to study enrollment unless medically contraindicated. If a patient undergoes surgery and lumbar CSF cytology cannot be obtained at the time of surgery, then it should be performed at least 10 days following surgery and prior to study enrollment. False positive cytology can occur within 10 days of surgery * Patients must have RAPID CENTRAL TUMOR MARKER REVIEW CSF tumor markers obtained prior to enrollment unless medically contraindicated. Ventricular CSF obtained at the time of CSF diversion procedure (if performed) is acceptable for tumor markers but lumbar CSF is preferred. In case CSF diversion and biopsy/surgery are combined, CSF tumor markers should be collected first * Peripheral absolute neutrophil count (ANC) \>= 1000/uL (within 7 days prior to enrollment) * Platelet count \>= 100,000/uL (transfusion independent) (within 7 days prior to enrollment) * Hemoglobin \>= 8.0 g/dL (may receive red blood cell \[RBC\] transfusions) (within 7 days prior to enrollment) * Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 or a serum creatinine based on age/gender as follows (within 7 days prior to enrollment): * Age: Maximum serum creatinine (mg/dL) * 3 to \< 6 years: 0.8 (male), 0.8 (female) * 6 to \< 10 years: 1 (male), 1 (female) * 10 to \< 13 years: 1.2 (male), 1.2 (female) * 13 to \< 16 years: 1.5 (male), 1.4 (female) * \>= 16 years: male (1.7), 1.4 (female) * Total bilirubin =\< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment) * Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 135 U/L (within 7 days prior to enrollment) * Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L * Central nervous system function defined as: * Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled * Patients must not be in status epilepticus, coma or assisted ventilation prior to study enrollment * Protocol therapy must begin within 31 calendar days of definitive surgery or clinical diagnosis, whichever is later. If a biopsy only was performed, the biopsy date will be considered the date of definitive surgery. For patients who have a biopsy or incomplete resection at diagnosis followed by additional surgery, the date of the last resection will be considered the date of definitive surgery. * All patients and/or their parents or legal guardians must sign a written informed consent * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met * NEUROCOGNITIVE FUNCTION AND QUALITY OF LIFE ASSESSMENT: * English-, Spanish-, or French- speaking * Note: Patients who speak a language other than English, Spanish, or French will be allowed to participate in ACNS2021 but will not complete the neurocognitive and quality of life assessments * No known history of neurodevelopmental disorder prior to diagnosis of NGGCT (e.g., Down syndrome, fragile X, William syndrome, intellectual disability). Patients with NF1 will be allowed to participate * Additional eligibility criteria for the COG Standardized Neuropsychological Battery only: must be at a site that has a psychologist to administer the battery * Note: If not eligible for the COG Standardized Battery, patients should still complete the Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2), Pediatric Quality of Life Inventory (PedsQL), Adaptive Behavior Assessment System Third Edition (ABAS-3), and Behavior Assessment System for Children, Third Edition (BASC-3) questionnaires

Exclusion Criteria:

* Patients with tumors located outside the ventricles (i.e., basal ganglia, thalamus) * Patients with only mature teratoma and non-elevated markers upon tumor sampling at diagnosis * Patients who have received any prior tumor-directed therapy for their diagnosis of NGGCT other than surgical intervention and corticosteroids * Patients with metastatic disease (i.e., MRI evaluation, lumbar CSF cytology or intraoperative evidence of dissemination) * Female patients who are pregnant, since fetal toxicities and teratogenic effects have been noted for several of the study drugs * Note: Serum and urine pregnancy tests may be falsely positive due to HCGbeta-secreting germ cell tumors. Ensure the patient is not pregnant by institutional standards * Lactating females who plan to breastfeed their infants * Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation

Interventions: PROCEDURE: Biospecimen Collection, DRUG: Carboplatin, DRUG: Etoposide, BIOLOGICAL: Filgrastim, DRUG: Ifosfamide, PROCEDURE: Magnetic Resonance Imaging, DRUG: Mesna, BIOLOGICAL: Pegfilgrastim, PROCEDURE: Peripheral Blood Stem Cell Transplantation, OTHER: Questionnaire Administration, RADIATION: Radiation Therapy, RADIATION: Radiation Therapy, PROCEDURE: Second-Look Surgery, DRUG: Thiotepa

Conditions: Central Nervous System Nongerminomatous Germ Cell Tumor, Choriocarcinoma, Embryonal Carcinoma, Immature Teratoma, Malignant Teratoma, Mixed Germ Cell Tumor, Pineal Region Germ Cell Tumor, Pineal Region Immature Teratoma, Pineal Region Yolk Sac Tumor, Suprasellar Germ Cell Tumor

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Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients Who Present With Symptomatic Heart Failure With Reduced Ejection Fraction (HFrEF): The CORCINCH-HF Study

Contact(s):

Amy Wolfe - Amy.Wolfe@PrismaHealth.org

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 18 years and over

Phase: NA

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT04331769

Show full eligibility criteria

Inclusion Criteria:

• Age 18-years or older
• Ejection Fraction: ≥20% and ≤40% measured by transthoracic echocardiography (TTE) and assessed by an echocardiography (echo) core lab
• LV end-diastolic diameter ≥55 mm measured by TTE and assessed by an echo core lab
• Symptom Status:
• NYHA III,
• NYHA ambulatory IV, or
• NYHA II with a heart failure hospitalization within the prior 12 months (of signing the consent)
• Able to complete six-minute walk test with distance between 100 m and 450 m.
• Diagnosis and treatment for heart failure should be established at least 90 days before the date of consent. Subjects should be on stable, optimally titrated medical therapy for at least 30 days, as recommended according to current guidelines as standard-of-care for Heart Failure therapy, with any intolerance documented.
• "Stable" is defined as no more than a 100% increase or a 50% decrease of total daily doses. Medication changes within this range do not require any additional waiting before the screening assessments
• When a total daily dose increase or decrease exceeds that which is considered stable, the screening TTE and CT will be postponed 30 days after the medication change
• When additional titration is required to optimize a subject's medication that exceeds what is considered stable, the screening TTE and CT will be postponed at least 30 days after achieving the optimal dose (provided the optimal dose remains outside of the stable parameters)
• When a dose-for-dose equivalent change in the class of medication change is made, no additional waiting is required before the screening assessments
• When a change in class medication change exceeds what is considered stable, OR a new class of medication is added, the screening TTE and CT will be postponed 30 days after the medication change
• If an SGLT2 inhibitor is added to a subject's medications, the screening TTE and CT will be postponed at least 30 days after the addition
• If an SGLT2 inhibitor dose changes per the stable definition above, no additional waiting is required before the screening assessments
• If an SGLT2 inhibitor dose change exceeds what is considered stable, the screening TTE and CT will be postponed at least 30 days after achieving the optimal dose (provided the dose remains outside of the stable parameters)
• When applicable, for guideline-directed device-based therapies: a CRT device must be placed \> 90 days before the screening TTE and CT, and an ICD must be placed \> 30 days before the screening TTE and CT
• Able and willing to complete all qualifying diagnostic and functional tests, willing to accept blood product transfusion if required and agrees to comply with study follow-up schedule

Exclusion Criteria:

Cardiovascular
• Myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 90 days prior to consent
• Untreated clinically significant coronary artery disease (CAD) requiring revascularization
• Fluoroscopic or echocardiographic evidence of severe aortic arch calcification, mobile aortic atheroma, intracardiac mass, thrombus or vegetation
• Suboptimal ventricular anatomy or wall thickness as determined from screening echocardiography and/or CT scan
• Heart failure on the basis other than ischemic or non-ischemic dilated cardiomyopathy (e.g., hypertrophic cardiomyopathy, amyloid cardiomyopathy, restrictive cardiomyopathy, uncorrected congenital heart disease, constrictive pericarditis)
• Hemodynamic instability within 30 days prior to the implant defined as subject requiring inotropic support or mechanical hemodynamic support
• Any planned cardiac surgery or interventions within the next 180 days post-randomization (including therapeutic right heart procedures)
• Active bacterial endocarditis
• Severe RV dysfunction assessed by right heart catheterization (RHC) and/or TTE
• Fixed pulmonary hypertension with PA systolic pressure \>70 mmHg not responsive to vasodilator therapy
• History of any stroke within the prior 90 days of consent or documented Modified Rankin Scale ≥ 2 disability from any prior stroke Valvular
• Mitral regurgitation grade 3+ (moderate-severe) or 4+ (severe)
• Untreated degenerative (primary) mitral valve disease (mild prolapse with no need for intervention is allowable)
• Prior mitral or aortic valve replacement
• Tricuspid regurgitation grade 4+ (severe)
• Moderate or severe aortic valve stenosis (AVA less than 1.5 cm2 or peak velocity AV Vmax \>300 cm/sec)
• Aortic regurgitation grade 2+ (moderate), 3+ (moderate-severe), or 4+ (severe) Procedural
• Anatomical pathology or constraints preventing appropriate access/implant of the AccuCinch Ventricular Restoration System (e.g., femoral arteries will not support a 20F Introducer sheath)
• Renal insufficiency (i.e., eGFR of \<25 ml/min/1.73 m2)
• Subjects in whom anticoagulation during the procedure is contraindicated
• Subjects in whom 90 days of antiplatelet therapy is contraindicated
• Known allergy to nitinol, polyester, or polyethylene
• Any prior true anaphylactic reaction to contrast agents; defined as known anaphylactoid or other non-anaphylactic allergic reactions to contrast agents that cannot be adequately pre-medicated prior to the index procedure General
• Life expectancy \<1 year due to non-cardiac conditions
• Currently participating in another interventional investigational study
• Subjects on high dose steroids or immunosuppressant therapy
• Female subjects who are pregnant, of child-bearing potential without a documented birth control method, or who are lactating

Interventions: DEVICE: AccuCinch Ventricular Restoration System, DRUG: Guideline-Directed Medical Therapy

Conditions: Heart Failure With Reduced Ejection Fraction (HFrEF), Dilated Cardiomyopathy

Keywords: Heart Failure, Reduced Ejection Fraction, Cardiomyopathy

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Shorter Chemo-Immunotherapy Without Anthracycline Drugs for Early-Stage Triple Negative Breast Cancer

Contact(s):

Alicia Aranda - aaranda@swog.org

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 18 years and over

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT05929768

Show full eligibility criteria

Inclusion Criteria:

* Participants must have histologically confirmed estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and HER2-negative breast cancer (TNBC) defined as ER \< 5%, PR \< 5%, and HER2 negative (per 2020 American Society of Clinical Oncology \[ASCO\] College of American Pathologists \[CAP\] guidelines) * NOTE: Participants with weakly ER or PR positive disease, defined as ER and/or PR between 1-4% by immunohistochemistry, are eligible if adjuvant endocrine therapy is not recommended/planned by the treating physician * Participants must have American Joint Committee on Cancer (AJCC) 8 anatomic tumor clinical stage either * T2-T4, N0, M0 or * T1-T3, N1-2, M0 * Note: All participants with clinically suspicious nodes must undergo core needle biopsy or fine needle biopsy per standard clinical practice to pathologically confirm nodal status * Participants must have breast and axillary imaging with mammogram and/or ultrasound and/or magnetic resonance imaging (MRI) within 49 days prior to randomization * Note: Participants with bilateral invasive breast cancer are eligible if both breast cancers are ER-negative, PR-negative, and HER2-negative provided they meet the other eligibility criteria * Participants must not have T4/N+, any N3, or inflammatory breast cancer * Participants must not have metastatic disease (M1) * Participants must not have received prior systemic therapy or radiation therapy with curative intent for the current breast cancer * Participants must not have had previous definitive ipsilateral breast surgery for the current breast cancer * Participants must not have current or anticipated use of other investigational agents while participating in this study * Participants must not have history of allergic reactions attributed to compounds of similar chemical or biologic composition as study agents * Participants must not have severe hypersensitivity (\>= grade 3) to pembrolizumab or any of its excipients * Participants must not have received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. CTLA-4, OX-40, CD137) * Participants must not be currently participating in or have participated in a study of an investigational agent or used an investigational device within 28 days prior to randomization * Participants must be \>= 18 years old * Participants must have Zubrod performance status of 0-2 * Participants with evidence of peripheral neuropathy must have it at =\< grade 1, by Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 5.0, within 28 days prior to randomization * Participants must have a complete medical history and physical exam within 28 days prior to randomization * Hemoglobin \>= 9.0 g/dL or \>= 5.6 mol/L (within 28 days prior to randomization) * (Criteria must be met without erythropoietin dependency and without packed red blood cell transfusion within last 2 weeks) * Leukocytes \>= 3 x 10\^3/uL (within 28 days prior to randomization) * Absolute neutrophil count \>= 1.5 x 10\^3/uL (within 28 days prior to randomization) * Platelets \>= 100 x 10\^3/uL (within 28 days prior to randomization) * Total bilirubin =\< 1.5 x institutional upper limit of normal (IULN), OR direct bilirubin =\< IULN for participants with total bilirubin \> 1.5 x IULN (unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =\< 5 x institutional IULN) (within 28 days prior to randomization) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3 x institutional upper limit of normal (ULN) (within 28 days prior to randomization) * Participants must have a serum creatinine =\< the IULN OR calculated creatinine clearance \>= 50 mL/min/1.73m\^2 using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration * Participants must have adequate cardiac function. Participants must have left ventricular ejection fraction \>= 50% as assessed by either echocardiography (ECHO) or multigated acquisition scan (MUGA) assessed within 28 days prior to registration. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification and must be class 2B or better * Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at randomization and have undetectable viral load test on the most recent test results obtained within 6 months prior to randomization * Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to randomization, if indicated * Note: No testing for Hepatitis B is required unless mandated by local health authority * Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to randomization, if indicated * Note: No testing for hepatitis C is required unless mandated by local health authority * Participants with history of diabetes must not have uncontrolled diabetes in the opinion of the treating investigator * Participants must not have uncontrolled hypertension in the opinion of the treating investigator * Participants must not have had a major surgery within 14 days prior to randomization. Participants must have fully recovered from the effects of prior major surgery in the opinion of the treating investigator * Participants must not have severe or active infections within 14 days prior to Randomization, including but not limited to hospitalization for infection, bacteremia, or severe pneumonia * Participants must not have a diagnosis of immunodeficiency and be receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization * Participants must not have active autoimmune disease that has required systemic treatment in 2 years prior to randomization (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment * Participants must not have a history of (non-infectious) pneumonitis that required steroids, or has current (non-infectious) pneumonitis * Participants must not have received a live vaccine within 30 days prior to randomization. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist \[registered trademark\]) are live attenuated vaccines and are not allowed * Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the treatment regimen * Participants must not be pregnant or nursing. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen * Participants must have one (1) physical 4-5-micron single hematoxylin and eosin (H\&E) slide from the archival pretreatment diagnostic biopsy available for submission * Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System * Participants who can complete questionnaires in English, Spanish, or French must be offered the opportunity to participate in the Patient-Reported Outcome study * NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines * For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations * As part of the registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

Interventions: PROCEDURE: Biospecimen Collection, DRUG: Carboplatin, DRUG: Cyclophosphamide, DRUG: Docetaxel, DRUG: Doxorubicin, DRUG: Paclitaxel, BIOLOGICAL: Pembrolizumab, OTHER: Quality-of-Life Assessment, OTHER: Questionnaire Administration, PROCEDURE: Surgical Procedure

Conditions: Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Early Stage Triple-Negative Breast Carcinoma

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The MIRROR Registry: Minimally Invasive IntRaceRebral HemORrhage Evacuation (MIRROR)

Contact(s):

Rosie Gaddy - rosie.gaddy@prismahealth.org

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 18 years and over

Phase:

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT04494295

Show full eligibility criteria

Interventions: DEVICE: Aurora Surgiscope System

Conditions: Supratentorial Hemorrhage

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A Study of RGX-202-01 (Ompenaclid) as Combination Therapy in RAS Mutant Advanced Colorectal Cancer

Contact(s):

Lisa Johnson - lisa.johnson@prismahealth.org

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 18 years and over

Phase: PHASE1

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT03597581

Show full eligibility criteria

Inclusion Criteria:

* The patient must have histologic or cytologic evidence of a RAS colorectal cancer of adenocarcinoma or poorly differentiated histology and must have disease that is resistant to or relapsed following available standard systemic therapy or for which there is no standard systemic therapy or reasonable therapy likely to result in clinical benefit or if such therapy has been refused by the patient. * The patient must have advanced disease, defined as cancer that is either metastatic or locally advanced and unresectable (and for which additional radiation therapy or other locoregional therapies are not considered feasible). * Pathologically documented adenocarcinoma or poorly differentiated locally advanced/metastatic colorectal cancer * Have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by the Investigator * Adults ≥18 years * Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 1 * Adequate cardiac function, as defined by left ventricular ejection fraction (LVEF) ≥45% * Adequate organ function * Prothrombin time ≤1.5 x ULN or international normalized ratio within ≤1.5; and either partial thromboplastin time or activated partial thromboplastin time ≤1.5 x ULN. Patients on warfarin may be included if on a stable dose with a therapeutic INR \<3.5 Inclusion Criteria for RGX-202-01 plus FOLFIRI and bevacizumab expansion stages: For the expansion stage only, patients must have a tumor that is laboratory-confirmed to be RAS mutant. * Must have received only one prior standard of care oxaliplatin-containing regimen for locally advanced/metastatic colorectal cancer (CRC) * Must have received prior treatment with pembrolizumab or an FDA approved PD-1/L1 inhibitor as well, if the patient has dMMR/MSI-H colorectal cancer * May have received prior treatment with bevacizumab, cetuximab, or panitumumab, or an FDA approved biosimilar. Exclusion Criteria for RGX-202-01 plus FOLFIRI and bevacizumab expansion stages: * Unresolved Grade \> 2 toxicities from prior anticancer therapy; excluding Grade 2 chemotherapy-related neuropathy, alopecia; and excluding Grade 2-3 asymptomatic laboratory abnormalities if considered clinically insignificant by the Investigator, or can be managed with available medical therapies * Has malignancy of small cell, neuroendocrine, or squamous histology * Unable to meet the requirement of an adequate treatment washout period before enrollment * Has additional malignancy that may confound the assessment of study endpoints. Participants with non-melanoma skin cancer, carcinoma in situ (including transitional cell carcinoma, cervical intraepithelial neoplasia, and melanoma in situ), organ-confined prostate cancer with no evidence of progressive disease are not excluded * Has clinically significant cardiovascular disease (New York Heart Association Class III or IV congestive heart failure, history of myocardial infarction, uncontrolled angina, unstable angina or stroke within 6 months before enrollment, uncontrolled hypertension or clinically significant arrhythmias not controlled by medication * Has clinically active brain or leptomeningeal metastases * Has uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, disseminated intravascular coagulation, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant or breast feeding * Has an ongoing chronic hepatopathy of any origin * Has an evidence of muscular dystrophies or ongoing muscle pathology * Has oxygen-support requirements * Has corrected QT interval (QTc) prolongation to \>470 ms (females) or \>450 ms (males) * Has a physical abnormality or medical condition that limits swallowing multiple pills or has a history of non-adherence to oral therapies * Has a malabsorption condition, such as short bowel syndrome, impaired GI function or GI disease that may significantly alter absorption, or a high likelihood of impending bowel obstruction, such as strictures * Has clinically significant ascites (i.e. requiring paracentesis within the preceding 28 days or treatment with pain medication) * Has a medical condition which, in the opinion of the Investigator, places the patient at an unacceptably high risk for toxicities Exclusion Criteria for RGX-202-01 plus FOLFIRI and bevacizumab dose escalation and expansion stages: * Has known dihydropyrimidine dehydrogenase (DPD) deficiency or is on treatment with DPD inhibitors, including sorivudine or its chemically related analogues such as brivudine, within 4 weeks prior to the start of treatment * Has known homozygous or heterozygous for UGT1A1\*28, UGT1A1\*6, UGT1A9\*1 or ABCG2 allele * Require treatment with strong CYP3A4 inhibitors or strong UGT1A1 inhibitors * Previously treated with FOLFIRI or other irinotecan containing regimens * Has proteinuria ≥ 2gm/24 and/or nephrotic syndrome. Patients with a proteinuria 2+ or greater urine dipstick reading should undergo further assessment, e.g., a 24-hour urine collection * History of acute or subacute intestinal occlusion - except if such an event occurred only around the time of diagnosis - or chronic inflammatory bowel disease or chronic diarrhea * History of severe, non-healing wounds, ulcers or bone fractures * History of arterial thromboemboli or severe hemorrhage within 6 months of prior FOLFIRI treatment with an exception of tumor bleeding before tumor resection surgery * History of hemorrhagic diathesis or tendency towards thrombosis

Inclusion Criteria:

FOLFOX/Bevacizumab Combination To be enrolled in this substudy, patients must meet all of the following criteria during the screening period:
• The patient has signed informed consent prior to initiation of any study-specific procedures or treatment.
• The patient must have previously untreated metastatic colorectal adenocarcinoma, defined as cancer that is metastatic and for which additional radiation therapy or other locoregional therapies in curative intent are not considered feasible or beneficial. Note that patients who have had previous systemic anticancer therapy as neoadjuvant or adjuvant therapy and had a metastatic recurrence at least 12 months after the last dose of adjuvant oxaliplatin will also be eligible.
• The patient must have a tumor that is laboratory-confirmed to be RAS-mutant based on the tumor tissue analysis. RAS-mutant status confirmation by liquid biopsy is acceptable only if the tumor sample is not available. For patients with newly diagnosed disease, RAS-mutant status must be obtained before initiation of therapy.
• The patient must have disease that is measurable by standard imaging techniques by RECIST version 1.1 or by physical examination methods (ruler or calipers). For patients with prior radiation therapy, measurable lesions must be outside of any prior radiation field(s), unless disease progression has been documented at that disease site subsequent to radiation.
• The patient is ≥ 18 years old.
• The patient has an ECOG Performance Score of ≤ 1.
• The patient has adequate baseline organ function, as demonstrated by the following:
• Serum creatinine ≤ 1.5 x institutional ULN and calculated creatinine clearance \> 50 mL/minute;
• Serum albumin ≥ 2.5 g/dl;
• Bilirubin ≤ 1.5 x institutional ULN or ≤ 2.5 x institutional ULN for patients with known Gilbert's disease;
• AST and ALT ≤ 2.5 x institutional ULN; patients with hepatic metastases may have AST and ALT ≤ 5 x institutional ULN;
• ANC ≥ 2.0 x 109/L;
• Hemoglobin ≥ 8 g/dL and no RBC transfusions during 14 days before the start of study treatments;
• Platelet count ≥ 100 x 109/L and no platelet transfusions during 14 days before the start of study treatments.
• For patients not taking anticoagulation therapy: INR ≤ 1.5 or PT ≤ 1.5 x ULN; and either PTT or aPTT ≤ 1.5 x ULN. Patients on warfarin/anticoagulation therapy may be included if on a stable dose with a therapeutic anticoagulation range.
• The patient has a LVEF ≥ 45% as determined by either ECHO or MUGA scanning.
• If the patient is a WOCBP, she has had a negative serum or urine pregnancy test within 2 weeks prior to treatment.
• Men and WOCBP agree to use acceptable contraceptive methods for the duration of time on the study and continue to use acceptable contraceptive methods for at least 6 months after the last dose of bevacizumab or 2 months after the last dose of ompenaclid, whichever is later.
• The patient is able to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria:

FOLFOX/Bevacizumab Combination Potential patients to be enrolled in the FOLFOX/bevacizumab combination phase of this study who meet any of the following criteria during the screening period will be excluded:
• Patients who have received neoadjuvant or adjuvant FOLFOX chemotherapy and have development of metastatic disease documented within 12 months after completion of oxaliplatin. • Patients may have received prior single agent fluoropyrimidine therapy if administered for the purpose of radiosensitization or as a single systemic agent (if the development of metastatic disease is documented at least 12 months from completion of neoadjuvant/adjuvant therapy).
• Any Grade neurotoxicity.
• Patients who have dMMR/MSI-H CRC.
• The patient has received treatment with chemotherapy, biological therapy, external-beam radiation, or other systemic anticancer therapy within 12 months prior to the administration of study treatments (42 days for prior nitrosourea or mitomycin-C).
• Known allergy or hypersensitivity to platinum-containing medications, 5-FU or leucovorin.
• Has an additional active malignancy that may confound the assessment of the study endpoints. Patients with a past cancer history with substantial potential for recurrence must be discussed with the Medical Monitor before study entry. Patients with the following concomitant neoplastic diagnoses are eligible: non-melanoma skin cancer, carcinoma in situ (including transitional cell carcinoma, cervical intraepithelial neoplasia, and melanoma in situ), organ-confined prostate cancer with no evidence of PD (Gleason ≤ 6).
• Clinically significant cardiovascular disease (e.g., uncontrolled or any New York Heart Association Class 3 or 4 congestive heart failure (see Section 13), uncontrolled angina, history of myocardial infarction, unstable angina or stroke within 6 months prior to study entry, uncontrolled hypertension (defined as SBP \> 160 mmHg or DBP \> 90 mmHg), or clinically significant arrhythmias not controlled by medication).
• History of arterial thromboembolism or severe hemorrhage within 6 months prior to inclusion in the study, with the exception of tumor bleeding before tumor resection surgery.
• Known or suspected active brain or leptomeningeal metastases. Pre-existing asymptomatic brain or leptomeningeal metastases should be stable with no need for steroid therapy. If the patient has had prior radiation, the washout for metastases or brain surgery is 14 days before the start of treatment. CNS imaging is not required prior to study entry unless there is a clinical suspicion of CNS involvement.
• Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, disseminated intravascular coagulation, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant or breast -eeding.
• Ongoing chronic hepatopathy of any origin.
• Clinically significant ascites (i.e., requiring paracentesis within the prior 28 days or medical treatment for abdominal pain).
• Evidence of muscular dystrophies or ongoing muscle pathology.
• Oxygen-support requirements.
• QTcF \> 450 msec (males) or \> 470 msec (females).
• Physical abnormality or medical condition that limits swallowing multiple pills or has a history of non-adherence to oral therapies.
• Gastrointestinal disorder(s) that would significantly impede the absorption of an oral agent.
• Known DPD deficiency or is on treatment with DPD inhibitors, including sorivudine or its chemically related analogues such as brivudine, within 4 weeks prior to the start of treatment.
• Marked proteinuria (≥ 2 g/24 h) and/or nephrotic syndrome. Patients with a proteinuria 2 + or greater on urinalysis/urine dipstick reading should undergo further assessment, e.g., a 24-hour urine collection.
• Severe, non-healing wounds, ulcers or bone fractures.
• History of hemorrhagic diathesis or tendency towards thrombosis that is not optimally managed.
• Medical condition not listed above which, in the opinion of the Investigator, places the patient at an unacceptably high risk for toxicities.

Interventions: DRUG: ompenaclid, DRUG: FOLFIRI, DRUG: Bevacizumab, DRUG: FOLFOX regimen

Conditions: Colorectal Cancer, Gastric Cancer, Gastrointestinal Cancer, Gastrointestinal Neoplasms, Colorectal Neoplasms, Colorectal Carcinoma, Gastric Neoplasm, KRAS Mutation-Related Tumors, CRC, Colorectal Cancer Metastatic

Keywords: SLC6a8, Creatine transporter, FOLFIRI, Colorectal Cancer, CRC, KRAS, Colorectal Cancer Metastatic, NRAS, RAS, FOLFOX

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Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors

Contact(s):

IRB@prismahealth.org

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age:

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT03067181

Show full eligibility criteria

Inclusion Criteria:

* There is no age limit for the low risk stratum (stage I ovarian immature teratoma and stage I non-seminoma or seminoma malignant GCT \[all sites\]) * Standard risk 1: Patients must be \< 11 years of age at enrollment * Standard risk 2: Patients must be \>= 11 and \< 25 years of age at enrollment * Patients enrolling on one of the low risk arms must be newly diagnosed with a stage I germ cell tumor; for the standard risk arms, patients must be newly diagnosed with metastatic germ cell tumor (stage II or higher); histologic confirmation of a primary extracranial germ cell tumor in any of the categories outlined below is required of all patients at enrollment except for those who were initially diagnosed with stage I non-seminoma malignant GCT and later recur during observation post surgery off study; for these patients, if elevated tumor markers rise to \> 5 x upper limit of normal (ULN) on at least 2 measurements taken at least 1 week apart, a diagnostic biopsy is not required for enrollment * Low risk stage I immature teratoma (IT); site: ovarian; stage: Children's Oncology Group (COG) stage I, Federation of Gynecology and Obstetrics (FIGO) stage IA and IB; grade: 2 or 3; histology: pure immature teratoma (may contain microscopic foci of yolk sac tumor), mixed immature and mature teratoma, (no pathological evidence of MGCT); tumor markers: alpha-FP =\< 1,000 ng/mL, beta-HCG institutional normal; all ages * Low risk stage I non-seminoma MGCT; site: ovarian, testicular, or extragonadal; stage: COG stage I, FIGO stage IA and IB, American Joint Committee on Cancer (AJCC) testicular stage IA, IB and IS; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or mixed); all ages * Low risk stage I seminoma-MGCT; site: testicular; stage: COG stage I; AJCC testicular stage IA IB, and IS; histology: may contain immature/mature teratoma; may NOT contain yolk sac tumor, embryonal carcinoma, or choriocarcinoma; all ages * Standard risk 1 (SR1); site: ovarian, testicular, or extragonadal; stage: COG stage II-IV, FIGO stage IC, FIGO stage II-IV (International Germ Cell Consensus Classification \[IGCCC\] criteria DO NOT apply); histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) \< 11 * Standard risk 2 (SR2) * Site: ovarian; stage: COG stage II and III, FIGO stage IC, II and III; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) \>= 11 and \< 25 * Site: testicular; stage: COG stage II-IV, AJCC stage II, III, IGCCC good risk; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; tumor markers: must be IGCCC good risk; post op: alpha-FP \< 1,000 ng/mL, beta-HCG \< 5,000 IU/mL and lactate dehydrogenase (LDH) \< 3.0 x normal; age (years) \>= 11 and \< 25 * Site: extragonadal; stage: COG stage II; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) \>= 11 and \< 25 * Notes: * IGCCC criteria only apply to SR2 patients with a testicular primary tumor * Use post-op tumor marker levels to determine IGCCC risk group * Stage 1 seminoma patients are not eligible for the standard risk arms of the study * For the low risk stage I non-seminoma MGCT and the standard risk arms, components of yolk sac tumor, embryonal carcinoma, or choriocarcinoma can be mixed with other forms of GCT, such as seminoma or mature or immature teratoma; if yolk sac tumor is the only malignant component present, then it must be deemed by the pathologist to be greater than a "microscopic component" of yolk sac tumor * Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, 2 or 3; use Karnofsky for patients \> 16 years of age and Lansky for patients =\< 16 years of age * Organ function requirements apply ONLY to patients who will receive chemotherapy (SR1 and SR2 patients) * Adequate renal function defined as: * Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 (within 7 days prior to enrollment) OR * A serum creatinine based on age/gender as follows (within 7 days prior to enrollment): (mg/dL) * 1 month to \< 6 months male: 0.4 female: 0.4 * 6 months to \< 1 year male: 0.5 female: 0.5 * 1 to \< 2 years male: 0.6 female: 0.6 * 2 to \< 6 years male: 0.8 female: 0.8 * 6 to \< 10 years male: 1 female: 1 * 10 to \< 13 years male: 1.2 female: 1.2 * 13 to \< 16 years: male: 1.5 female: 1.4 * \>= 16 years male: 1.7 female: 1.4 * Total bilirubin =\< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment) * Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) \< 2.5 x upper limit of normal (ULN) for age (for the purpose of this study, the ULN for SGPT is 45 U/L) (within 7 days prior to enrollment) * Peripheral absolute neutrophil count (ANC) \>= 1,000/mm\^3 (within 7 days prior to enrollment) AND * Platelet count \>= 100,000/mm\^3 (within 7 days prior to enrollment) * Patients enrolling on the standard risk arms must be medically fit to receive protocol treatment and with no contraindications to protocol treatment * Eligibility criteria to participate in the pilot study of the AYA-Hears instrument (patient reported outcomes \[PROs\] of ototoxicity) Note: participants in group 1 will not receive AGCT1531 protocol-directed therapy; all other AYA-HEARS patients must be enrolled on the AGCT1531 SR2 arm in order to participate * \>= 11 and \< 25 years old at enrollment * Able to fluently speak and read English * Has received prior cisplatin- or carboplatin-based chemotherapy regimen for malignancy including diagnoses other than germ cell tumor * Followed for cancer or survivorship care at one of the following institutions: * Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center * Dana Farber/Harvard Cancer Center * Hospital for Sick Children * Children's Hospital of Eastern Ontario * Oregon Health and Science University * Seattle Children's Hospital * Yale University

Exclusion Criteria:

* Patients with any diagnoses not listed including: * Stage I testicular cancer patients who have undergone primary RPLND (retroperitoneal lymph node dissection) * Pure dysgerminoma * Pure mature teratoma * Pure immature teratoma COG stage I, grade I * Pure immature teratoma COG stage I, grade 2,3 with alpha-fetoprotein (AFP) \>= 1000 ng/mL * Pure immature teratoma COG stage II - IV or FIGO stage IC to IV * "Poor risk" GCT (age \>= 11 years old and COG stage IV ovarian, COG stage III or IV EG, or IGCCC intermediate or poor risk testicular), or * Primary central nervous system (CNS) germ cell tumor * Germ cell tumor with somatic malignant transformation * Spermatocytic seminoma * Patients must have had no prior systemic therapy for the current cancer diagnosis * Patients must have had no prior radiation therapy with the exception of CNS irradiation of brain metastases; (this exception only applies to SR1 patients; any patients over age 11 with distant metastases to brain \[stage IV disease\] would be considered poor risk and therefore not eligible for this trial) * Patients with significant, pre-existing co-morbid respiratory disease that contraindicate the use of bleomycin are ineligible for the standard risk arms of the trial * Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs; a pregnancy test is required for female patients of childbearing potential; (this criteria applies ONLY to patients who will receive chemotherapy \[SR1 and SR2 patients\]) * Lactating females who plan to breastfeed their infants; (this criteria applies ONLY to patients who will receive chemotherapy \[SR1 and SR2 patients\]) * Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation; (this criteria applies ONLY to patients who will receive chemotherapy \[SR1 and SR2 patients\])

Interventions: OTHER: Best Practice, PROCEDURE: Biopsy, PROCEDURE: Biospecimen Collection, BIOLOGICAL: Bleomycin Sulfate, DRUG: Carboplatin, DRUG: Cisplatin, PROCEDURE: Computed Tomography, DRUG: Etoposide, PROCEDURE: Magnetic Resonance Imaging, OTHER: Pharmacogenomic Study, PROCEDURE: Pulmonary Function Test, OTHER: Quality-of-Life Assessment, OTHER: Questionnaire Administration

Conditions: Childhood Extracranial Germ Cell Tumor, Extragonadal Embryonal Carcinoma, Germ Cell Tumor, Malignant Germ Cell Tumor, Stage I Ovarian Embryonal Carcinoma AJCC v6 and v7, Stage I Ovarian Teratoma AJCC v6 and v7, Stage I Ovarian Yolk Sac Tumor AJCC v6 and v7, Stage I Testicular Choriocarcinoma AJCC v6 and v7, Stage I Testicular Embryonal Carcinoma AJCC v6 and v7, Stage I Testicular Seminoma AJCC v6 and v7, Malignant Ovarian Teratoma, Stage I Ovarian Choriocarcinoma, Stage I Testicular Yolk Sac Tumor AJCC v6 and v7, Stage II Ovarian Choriocarcinoma, Stage II Ovarian Embryonal Carcinoma AJCC v6 and v7, Stage II Ovarian Yolk Sac Tumor AJCC v6 and v7, Stage II Testicular Choriocarcinoma AJCC v6 and v7, Stage II Testicular Embryonal Carcinoma AJCC v6 and v7, Stage II Testicular Yolk Sac Tumor AJCC v6 and v7, Stage III Ovarian Choriocarcinoma, Stage III Ovarian Embryonal Carcinoma AJCC v6 and v7, Stage III Ovarian Yolk Sac Tumor AJCC v6 and v7, Stage III Testicular Choriocarcinoma AJCC v6 and v7, Stage III Testicular Embryonal Carcinoma AJCC v6 and v7, Stage III Testicular Yolk Sac Tumor AJCC v6 and v7, Stage IV Ovarian Choriocarcinoma, Stage IV Ovarian Embryonal Carcinoma AJCC v6 and v7, Stage IV Ovarian Yolk Sac Tumor AJCC v6 and v7, Testicular Mixed Choriocarcinoma and Embryonal Carcinoma, Testicular Mixed Choriocarcinoma and Teratoma, Testicular Mixed Choriocarcinoma and Yolk Sac Tumor

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Validation of a Salivary miRNA Diagnostic Test for ASD

Contact(s):

Andrew Brindle - abrindle@quadrantbiosciences.com

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 18 months to 7 years old

Phase:

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT05418023

Show full eligibility criteria

Interventions: OTHER: Salivary Collection, OTHER: Adaptive Assessment, OTHER: Medical and Demographic questionnaire, OTHER: Autism Assessment, OTHER: Intellectual Development Assessment

Conditions: Autism Spectrum Disorder, Developmental Delay

Keywords: Autism Spectrum Disorder, ASD, Saliva, Biomarkers

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MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)

Contact(s):

Site Public Contact - Kim.Williams3@prismahealth.org

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 18 years and over

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT05564390

Show full eligibility criteria

Inclusion Criteria:

* Participants must be suspected to have previously untreated acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Participants with AML cannot have a history of previously treated myeloproliferative neoplasms (MPN) or MDS. * Participants must be \>= 18 years of age. * Participants must not have received prior anti-cancer therapy for AML or MDS. * Note: Hydroxyurea to control the white blood cell count (WBC) is allowed. * Note: Prior erythroid stimulating agent (ESA) is not considered prior therapy for the purposes of eligibility. Participants must not be currently receiving any cytarabine-containing therapy other than up to 1 g/m\^2 of cytarabine, which is allowed for urgent cytoreduction. * Participants are allowed prior use of hydroxyurea, all-trans retinoic acid (ATRA), BCR-ABL directed tyrosine kinase inhibitor, erythropoiesis-stimulating agent, thrombopoietin receptor agonist and lenalidomide, with a maximum limit of 1 month of exposure. * Note: Participants receiving hydroxyurea prior to treatment substudy or TAP assignment must agree to discontinue hydroxyurea within 24 hours before beginning substudy or TAP treatment. * Participants must not have a prior or concurrent malignancy that requires concurrent anti-cancer therapy * Note: active hormonal therapy is allowed * Participants must have a Zubrod Performance Status evaluation within 28 days prior to registration. * Participants must agree to have translational medicine specimens submitted. * Participants must be offered the opportunity to participate in specimen banking. * Note: Specimens must be collected and submitted following the initial paper-based process and subsequently via the Precision Medicine Specimen Tracking Forms in Medidata Rave instance for the MyeloMATCH MSRP. * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. * Note: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system. * The master screening and reassessment protocol (MSRP) should only be used in sites where the relevant AML treatment substudies are open or if the site is willing to follow the MSRP Tier Advancement Pathway (TAP) for patients in the event that the site does not have the relevant study open and transfer to another site that does have the study open. For example, if a site does not have a myeloMATCH Tier 1 study for older AML open for enrollment, such older AML patients should only be consented for the MSRP if the site is willing to treat the patient with standard of care on TAP or is willing to transfer the patient to a center with a study open that the patient would otherwise match to.

Interventions: DRUG: Azacitidine, OTHER: Best Practice, PROCEDURE: Biopsy, PROCEDURE: Biospecimen Collection, PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, DRUG: Cytarabine, DRUG: Daunorubicin Hydrochloride, DRUG: Decitabine and Cedazuridine, PROCEDURE: Echocardiography, DRUG: Enasidenib, DRUG: Gilteritinib, DRUG: Liposome-encapsulated Daunorubicin-Cytarabine, PROCEDURE: Multigated Acquisition Scan, PROCEDURE: Mutation Carrier Screening, DRUG: Venetoclax

Conditions: Acute Myeloid Leukemia, Myelodysplastic Syndrome

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Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder for Bladder Cancer Treatment, MODERN Study

Contact(s):

Site Public Contact - Kim.Williams3@prismahealth.org

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 18 years and over

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT05987241

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Inclusion Criteria:

* PRE-REGISTRATION: Histologically confirmed muscle-invasive urothelial carcinoma of the bladder. Variant histology, including neuroendocrine differentiation, is allowed if urothelial cancer is predominant histology (any amount of squamous differentiation is allowed provided the tumor is not a pure squamous cell cancer) * PRE-REGISTRATION: Patient must have had radical cystectomy and lymph node dissection \>= 3 weeks, but =\< 12 weeks prior to pre-registration. Patients who have had a partial cystectomy as definitive therapy are not eligible * PRE-REGISTRATION: No gross cancer at the surgical margins. Microscopic invasive urothelial carcinoma at the surgical margins (i.e., "positive margins") are allowed. Carcinoma in situ (CIS) at margins is considered negative margins * PRE-REGISTRATION: No evidence of residual cancer or metastasis after cystectomy (imaging is not required prior to pre-registration but is required prior to registration) * PRE-REGISTRATION: Have undergone a radical cystectomy with pathological evidence of urothelial carcinoma of the bladder at high risk of recurrence as described in one of the two scenarios below (i or ii). The 7th edition of American Joint Committee on Cancer (AJCC) staging will be utilized.: * (i) Patients who have not received neoadjuvant cisplatin-based chemotherapy: pT3-pT4\* or pT0/x-pT4/N+ on cystectomy and are not eligible for adjuvant cisplatin chemotherapy * (i) Patients ineligible for cisplatin due to at least one of the following criteria and reason for ineligibility should be documented: * (i) Creatinine Clearance (using Cockcroft-Gault): \< 60 mL/min * (i) Common Terminology Criteria for Adverse Events (CTCAE) version 5, grade \>= 2 audiometric hearing loss * (i) CTCAE version 5, grade \>= 2 or above peripheral neuropathy * New York Heart Association Class III heart failure * (i) Eastern Cooperative Oncology Group (ECOG) performance status = 2 * (i) Patients who are eligible for cisplatin may be candidates if they refuse available adjuvant chemotherapy, despite being informed by the investigator about the treatment options. The patient's refusal must be documented. * (i) Patients with pT2N0 urothelial cancer on cystectomy (without prior neoadjuvant chemotherapy) with ctDNA(+) Signatera results based on an assay performed post-cystectomy as part of routine care outside of the study may proceed with pre-registration but require confirmation of ctDNA(+) Signatera testing on repeat "central testing" in the context of A032103 testing. Patients with pT2N0 with central testing not confirming ctDNA(+) will not be eligible for A032103 (Note: this is distinct from patients with ypT2N0 who are eligible based on ii). * (ii) Patients who received cisplatin-based neoadjuvant chemotherapy: ypT2-ypT4 or ypT0/x-pT4/N+ on cystectomy * PRE-REGISTRATION: Available tumor tissue for central Signatera testing to be submitted after pre-registration. Central testing is defined as testing performed as part of the A032103 study prior to registration and is provided by the study and not routine standard commercial testing. Patients who have already had Signatera testing performed as part of routine care will require repeat central testing as part of the A032103 study to be eligible for registration/randomization. Tumor tissue from the cystectomy is preferred over tissue from prior transurethral resection * PRE-REGISTRATION: Age \>= 18 years * PRE-REGISTRATION: ECOG Performance Status 0-2 * PRE-REGISTRATION: Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects * PRE-REGISTRATION: No postoperative/adjuvant systemic therapy after cystectomy * PRE-REGISTRATION: No adjuvant radiation after cystectomy * PRE-REGISTRATION: No treatment with any other type of investigational agent =\< 4 weeks before pre-registration * PRE-REGISTRATION: Not have ever received prior treatment with PD-1/PD-L1 blockade. * PRE-REGISTRATION: Not have ever received prior treatment with LAG-3 blockade. * PRE-REGISTRATION: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial * PRE-REGISTRATION: Absolute Neutrophil Count (ANC) \>= 1,200/mm\^3 * PRE-REGISTRATION: Platelet count \>= 100,000/mm\^3 * PRE-REGISTRATION: Hemoglobin \>= 8 g/dL * PRE-REGISTRATION: Creatinine =\< 1.5 x upper limit of normal (ULN) or calculated (calc.) creatinine clearance \> 30 mL/min (using either Cockcroft-Gault formula or Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation * PRE-REGISTRATION: Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3 x ULN * PRE-REGISTRATION: Total bilirubin =\< 1.5 x upper limit of normal (ULN) (except in patients with Gilbert Syndrome, who can have total bilirubin \< 3.0 mg/dL) * PRE-REGISTRATION: For women of childbearing potential only: A negative urine or serum pregnancy test done =\< 14 days prior to pre-registration is required * PRE-REGISTRATION: Not currently requiring hemodialysis * PRE-REGISTRATION: No current or prior history of myocarditis * PRE-REGISTRATION: No active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids. These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens- Johnson syndrome, or phospholipid syndrome because of the risk of recurrence or exacerbation of disease. * PRE-REGISTRATION: Patients with vitiligo, endocrine deficiencies including type I diabetes mellitus, thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible. * PRE-REGISTRATION: Patients with rheumatoid arthritis and other arthropathies, Sjögren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible. * PRE-REGISTRATION: No current pneumonitis or prior history of non-infectious pneumonitis that required steroids within the previous 5 years. * PRE-REGISTRATION: No known active hepatitis B (e.g., hepatitis B surface antigen \[HBsAg\] reactive) or hepatitis C (e.g., hepatitis C virus \[HCV\] ribonucleic acid \[RNA\] \[qualitative\] is detected). * PRE-REGISTRATION: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. * PRE-REGISTRATION: Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible. * PRE-REGISTRATION: No concurrent antineoplastic therapy. * PRE-REGISTRATION: No current immunosuppressive agents (with the exception of corticosteroids as described below). * PRE-REGISTRATION: No condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of pre-registration (with the exception of steroid pre-medications for contrast allergies). Inhaled or topical steroids and adrenal replacement doses \< 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. * REGISTRATION: Patient must have had radical cystectomy and lymph node dissection =\< 18 weeks prior to registration. * REGISTRATION: Must have evaluable ctDNA Signatera assay result (i.e., ctDNA\[+\]or ctDNA\[-\]) based on test performed as part of central testing after pre-registration to A032103. Central testing is defined as testing performed as part of the A032103. Local/commercial testing results may not be used for registration to A032103 * Cisplatin-ineligible (or cisplatin-declining) patients with a pT2N0 urothelial cancer on cystectomy who were pre-registered based on routine standard care ctDNA(+) Signatera testing must have confirmed ctDNA(+) Signatera testing on central testing. If central Signatera testing yields a ctDNA(-) result, these patients are ineligible. NOTE: This is a distinct consideration from patients with ypT2-4 and/or ypN+ urothelial cancer (i.e., patients who had received neoadjuvant cisplatin-based chemotherapy) who are eligible with either ctDNA(+) or ctDNA(-) central Signatera testing * REGISTRATION: All patients must have confirmed disease-free status defined as no measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, or definitive non-measurable radiographic metastatic disease, within 60 days prior to registration. Patients with equivocal nodes less than 15 mm in short axis, or \< 10 mm in long axis for non-lymph node lesions, not considered by the investigator to represent malignant disease will be eligible. Attempts should be made to resolve the etiology of equivocal lesions with complementary imaging (e.g., PET scan) or biopsy. * REGISTRATION: No major surgery =\< 3 weeks before registration. * REGISTRATION: No live vaccine within 30 days prior to registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette- Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist \[registered trademark\]) are live attenuated vaccines and are not allowed. Coronavirus disease 2019 (COVID-19) vaccines are not live vaccines and are allowed * COHORT B, ARM 4 PATIENTS INITIATING NIVOLUMAB AFTER CONVERSION OF ctDNA ASSAY FROM ctDNA(-) to ctDNA (+): * Patient must have converted to ctDNA(+) during serial monitoring performed centrally in the setting of the A032103 study * COHORT B, ARM 4 PATIENTS INITIATING NIVOLUMAB AFTER CONVERSION OF ctDNA ASSAY FROM ctDNA(-) to ctDNA (+): * No evidence of metastatic disease on the most recent scheduled imaging assessment as outlined in the study calendar (no repeat imaging is necessary specifically at the time of the conversion from ctDNA\[-\] to ctDNA\[+\]). * COHORT B, ARM 4 PATIENTS INITIATING NIVOLUMAB AFTER CONVERSION OF ctDNA ASSAY FROM ctDNA(-) to ctDNA (+): * No change in clinical condition and/or laboratory tests that would impact the safety of nivolumab in the opinion of the treating investigator * COHORT B, ARM 4 PATIENTS INITIATING NIVOLUMAB AFTER CONVERSION OF ctDNA ASSAY FROM ctDNA(-) to ctDNA (+): * =\< 6 weeks from reporting of ctDNA(+) result by Natera.

Interventions: PROCEDURE: Biospecimen Collection, OTHER: cfDNA or ctDNA Measurement, PROCEDURE: Computed Tomography, PROCEDURE: Magnetic Resonance Imaging, BIOLOGICAL: Nivolumab, OTHER: Quality-of-Life Assessment, OTHER: Questionnaire Administration, BIOLOGICAL: Relatlimab

Conditions: Muscle Invasive Bladder Urothelial Carcinoma, Stage II Bladder Urothelial Carcinoma AJCC v6 and v7, Stage III Bladder Urothelial Carcinoma AJCC v6 and v7, Stage IV Bladder Urothelial Carcinoma AJCC v7

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Feasibility and Efficacy Study of the CardioPulmonary Monitoring (CPM) System in Patients With Chronic Heart Failure

Contact(s):

Rebecca Rebain - Rebecca.Rebain@PrismaHealth.org

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 18 years and over

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT05978518

Show full eligibility criteria

Interventions: DEVICE: CPM Device + Monitoring, DRUG: CPM Device

Conditions: Heart Failure

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Nectero EAST System Clinical Study (stAAAble)

Contact(s):

Kya Spann - Kya.Spann@prismahealth.org

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 21 years to 85 years old

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06001918

Show full eligibility criteria

Inclusion Criteria:

• Males and females ≥21 - ≤85 years of age. Females must be of non-childbearing potential (menopause or sterilization).
• Subject understands the purpose of the trial, agrees to voluntarily participate in the trial, signs the informed consent and is willing to complete the follow-up according to the requirements of the protocol.
• Infrarenal atherosclerotic fusiform abdominal aortic aneurysm from 3.5 cm to 5.0 cm (male) and 3.5 cm to 4.5 cm (female).
• Infrarenal aortic neck ≥ 15 mm in length and ≤ 29 mm in diameter.
• Overall AAA treatment length (distal renal to distal inferior margin of the aneurysm) not to exceed 130 mm.
• Iliac and femoral artery access, vessel size and morphology allow endovascular access of 14F (or larger) introducer sheaths and catheters.
• Subject meets American Society of Anesthesiology (ASA) grade 1 through 3 criteria, inclusive.
• Subject has \> three-year life expectancy.
• Subject is able and willing to comply with all required follow-up clinic visits including CT scans (pre-randomization, 6, 12, 18, 24 months and annually up to 5 years).

Exclusion Criteria:

• Subject has an acutely ruptured, leaking, dissecting or emergent aneurysm.
• Subject has a symptomatic infrarenal abdominal aortic aneurysm.
• Subject has a mycotic or infected aneurysm.
• Subject has current vascular injury due to trauma.
• Subject's aneurysm is thoracic, suprarenal or juxtarenal.
• Previous surgical or endovascular aneurysm repair for abdominal aortic aneurysm.
• Subject has anatomy of diffuse, ulcerated, or extensive (shaggy) thrombus in the neck of the AAA, that in the opinion of the vascular surgeon/investigator, could result in embolization of the thrombus.
• Subject has anatomy of calcification, and/or plaque within the ilio-femoral arteries or severe infrarenal neck angulation that may compromise or does not allow delivery of the Introducer Sheath or the delivery catheter of the Nectero EAST System.
• Subject has had a myocardial infarction within six (6) months prior to enrollment or elevated CK enzymes or troponin prior to procedure.
• Subject has current angina, unstable angina, or other active cardiac condition such as congestive heart failure III and IV, atrial arrhythmia, ventricular arrhythmia, or valvular disease, requiring intervention.
• Subject has undergone other major surgery within the 30 days prior to enrollment.
• Subjects with any transient ischemic attack (TIA) or ischemic stroke within 3 months.
• Known allergy to contrast material, delivery system materials (i.e., nylon, polyurethane) and/or Pentagalloyl Glucose (PGG).
• Subject is morbidly obese or has other clinical conditions that severely inhibit X-ray visualization of the aorta.
• Subject has connective tissue/collagen disorder (e.g., Marfan syndrome, vascular Ehlers-Danlos Syndrome, Loeys-Dietz Syndrome, Eaton Syndrome, Bessel-Hagen disease, etc.).
• Known contraindication to undergoing angiography or receiving systemic anticoagulation.
• Subject has active systemic infection.
• Subject is participating in another research trial that could interfere with the results of the trial (e.g., drug trial).
• Subject has other medical, social, or psychological problems that, in the opinion of the investigator, preclude them from participation in the trial and to undergo the procedures and evaluations pre- and post-treatment.
• Subject has dialysis dependent renal failure or baseline serum creatinine level \>2.5mg/dL or eGFR \< 45 mL/min/1.73m2.
• Subjects with liver dysfunction: alanine transaminase (ALT) or aspartate transaminase (AST) which is 3 times higher than the normal upper limit; serum total bilirubin (STB) that is 1.5 times higher than the normal upper limit or has clinical evidence of jaundice.
• Subjects that may not tolerate the lowering of their systolic blood pressure to approximately 100mmHg, should not be considered for this study or treated using the Nectero EAST System.
• Subjects that may not be able to tolerate transient occlusion of the aorta should not be considered for this study.
• Subjects with saccular AAA.
• Subjects with rapidly expanding AAA (previous diameter increases of ≥0.5 cm in 6-months or ≥1 cm in 1 year) as these should be evaluated for immediate repair.
• Subjects who are not suitable for the Nectero EAST System treatment, as determined by the investigator.

Interventions: DRUG: Nectero EAST System

Conditions: Abdominal Aortic Aneurysm

Keywords: Abdominal Aortic Aneurysm

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Kaneka IED Coil System for the Treatment of Wide Necked Ruptured and Unruptured Intracranial Aneurysms (CLASS)

Contact(s):

Sydney Edwards - sydney.edwards@mountsinai.org

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 18 years to 80 years old

Phase: NA

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT05636124

Show full eligibility criteria

Inclusion criteria: * Patient presenting with ruptured or unruptured cerebral aneurysm appropriate for endovascular treatment as determined by the neuroendovascular treating team * Wide neck side wall or bifurcation intracranial aneurysms (neck \> or = to 4 mm or dome-to-neck ratio \< 2) within the anterior or posterior circulation * The neurointerventionist feels that the aneurysm can be safely treated using endovascular techniques (direct or assisted coiling) * Patients are 18-80 years of age (inclusive) * Patient must be Hunt and Hess grade 0 to 3 * Patient has given fully informed consent to endovascular coiling procedure. If the patient cannot consent for themselves, appropriate written consent has been sought from their next of kin or appropriate power of attorney. * Aneurysm 6-14 mm in diameter * Patient is willing and able to return for clinical evaluation and follow-up imaging evaluation (angiography) at 3-6 months and 12-18 months after endovascular treatment * The patient has not been previously enrolled in this trial or another related ongoing trial * The aneurysm has not been previously treated by coiling or clipping Exclusion criteria: * Patient has more than one aneurysm requiring treatment in the current treatment session, and only one of those to be treated aneurysms fits the Kaneka inclusion criteria (i.e., - if either (1) a patient has multiple aneurysms, but only one will be treated at enrollment; or (2) if two or more aneurysms are treated during the current treatment session and BOTH are able to be enrolled, then they remain eligible for the trial). Non-treated additional aneurysms may be treated at a later date with any coil type that the operator chooses). * Target aneurysm has had previous coil treatment or has been surgically clipped * Hunt and Hess score is 4 or 5 after subarachnoid hemorrhage * Inability to obtain informed consent * Medical or surgical comorbidity such that the patient's life expectancy is less than 2 years

Interventions: DEVICE: Kaneka i-ED coil

Conditions: Intracranial Aneurysms, Wide Neck Intracranial Aneurysms

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A Wrist-Worn Nerve Stimulator for Remediating Persistent Post-Concussive Symptoms in Adolescents

Contact(s):

Jacob Kay, PhD - jacob.kay@prismahealth.org

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 10 years and over

Phase: NA

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT05685121

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Interventions: DEVICE: Apollo Neuro

Conditions: Concussion, Brain

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Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer (M&M)

Contact(s):

Karen Craver - NCORP@wakehealth.edu

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 60 years and over

Phase:

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT03998202

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Conditions: Colorectal Cancer, Sarcopenia

Keywords: Colorectal Cancer, Myopenia, Sarcopenia, Chemotherapy, Geriatric-Oncology

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Electrical DN as an Adjunct to Eccentric Exercise, Stretching + MT for Achilles Tendinopathy

Contact(s):

Kris Phillips, DPT - Kris.Phillips@prismahealth.org

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 18 years and over

Phase: NA

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT03968614

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Interventions: OTHER: Electric dry needling and conventional PT, OTHER: Conventional PT

Conditions: Achilles Tendinopathy

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Genetic Testing in Screening Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (The ALCHEMIST Screening Trial)

Contact(s):

Site Public Contact - Kim.Williams3@prismahealth.org

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 18 years and over

Phase: NA

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT02194738

Show full eligibility criteria

Inclusion Criteria:

* PATIENT PRE-REGISTRATION ELIGIBILITY CRITERIA: * For pre-surgical patients * Suspected diagnosis of resectable non-small cell lung cancer; cancers with a histology of "adenosquamous" are considered a type of adenocarcinoma and thus a "nonsquamous" histology; patients with squamous cell carcinoma are eligible * Suspected clinical stage of IIIA, II (IIA or IIB) or large IB (defined as size \>= 4 cm); Note: IB tumors \< 4 cm are NOT eligible; stage IB cancer based on pleural invasion is not eligible unless the tumor size is \>= 4 cm; the 7th edition of American Joint Committee on Cancer (AJCC) staging will be utilized * For post-surgical patients * Completely resected non-small cell lung cancer with negative margins (R0); patients with squamous cell carcinoma are eligible only if they have not received adjuvant therapy * Pathologic stage IIIA, II (IIA or IIB) or large IB (defined as size \>= 4 cm); Note: IB tumors \< 4 cm are NOT eligible; stage IB cancer based on pleural invasion is not eligible unless the tumor size is \>= 4 cm; the 7th edition of AJCC staging will be utilized * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Age ≥ 18 years * No patients who have received neoadjuvant therapy (chemo- or radio-therapy) for this lung cancer * No locally advanced or metastatic cancer requiring systemic therapy within 5 years prior to registration; no secondary primary lung cancer diagnosed concurrently or within 2 year prior to registration * No prior treatment with agents targeting EGFR mutation, ALK rearrangement, and PD-1/PD-L1/CTLA-4 * No patients known to be pregnant or lactating * Patients who have had local genotyping are eligible, regardless of the local result * No patients with recurrence of lung cancer after prior resection * Note: Post-surgical patients should proceed to registration immediately following preregistration * PATIENT REGISTRATION ELIGIBILITY CRITERIA: * Tissue available for the required analyses (either clinical tissue block or slides and scrolls) * Completely resected NSCLC with negative margins (R0); cancers with a histology of "adenosquamous" are considered a type of adenocarcinoma and thus a "nonsquamous" histology * Pathologic stage IIIA, IIA or IIB, or large IB (defined as size \>= 4 cm); Note: IB tumors \< 4 cm are NOT eligible; stage IB cancer based on pleural invasion is not eligible unless the tumor size is \>= 4 cm; the 7th edition of AJCC staging will be utilized * Patients with squamous cell carcinoma are eligible only if they have not received adjuvant therapy * In order to allow for time for central genotyping and eligibility for the ALCHEMIST treatment trial, patients must register within the following eligibility windows: * Squamous patients: * No adjuvant therapy permitted, register patient within 77 days following surgery * Non-squamous patients: * If no adjuvant therapy, register patient within 75 days following surgery * If adjuvant chemotherapy or radiotherapy only, register patient within 225 days following surgery * If adjuvant chemotherapy and radiation, register patient within 285 days following surgery

Interventions: PROCEDURE: Biospecimen Collection, DRUG: Carboplatin, DRUG: Cisplatin, OTHER: Clinical Observation, PROCEDURE: Computed Tomography, DRUG: Crizotinib, OTHER: Cytology Specimen Collection Procedure, PROCEDURE: Echocardiography, DRUG: Erlotinib, DRUG: Gemcitabine Hydrochloride, BIOLOGICAL: Nivolumab, DRUG: Paclitaxel, BIOLOGICAL: Pembrolizumab, DRUG: Pemetrexed, DRUG: Pemetrexed Disodium, OTHER: Placebo Administration, PROCEDURE: Positron Emission Tomography

Conditions: Stage IB Lung Non-Small Cell Carcinoma AJCC v7, Stage II Lung Non-Small Cell Cancer AJCC v7, Stage IIA Lung Cancer AJCC v8, Stage IIB Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8, Stage IIIA Lung Non-Small Cell Cancer AJCC v7, Stage IIIB Lung Cancer AJCC v8

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BXQ-350 in Newly Diagnosed Metastatic Colorectal Carcinoma (ASIST)

Contact(s):

Bexion Pharmaceuticals, Inc. - clinicaltrialinfo@bexionpharma.com

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 18 years and over

Phase: PHASE1

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT05322590

Show full eligibility criteria

Inclusion Criteria:

Participants who meet the following criteria will be considered eligible to participate in the clinical study:
• Age ≥ 18 years of age at the time of signing the informed consent.
• Participants have newly diagnosed Stage IV metastatic adenocarcinoma of the colon / rectum.
• Have measurable disease at baseline based on RECIST 1.1 as determined by the local site Investigator / radiology assessment.
• Have a life expectancy \> 3 months.
• Have ECOG Performance Status of 0 or 1. * Participants unable to walk because of paralysis, but who can sit without assistance/restraint and control a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
• Have acceptable liver function defined as: * Total serum bilirubin ≤ 1.5 x upper limit of normal (ULN) for the study site; in participants with known Gilbert Syndrome, total bilirubin ≤ 3 x ULN, with direct bilirubin ≤ 1.5 x ULN). * Aspartate transaminase (AST), serum glutamic oxaloacetic transaminase (SGOT), alanine transaminase (ALT), serum glutamic pyruvic transaminase (SGPT) ≤ 3 x ULN (if liver metastases are present, then ≤ 5 x ULN is allowed). * Serum albumin ≥ 3 g/ dL.
• Have acceptable renal function defined as: * Creatinine clearance ≥ 50 mL/minute calculated using the Cockcroft-Gault formula (Cockcroft 1976): CCr = {((140 - age) x weight kg) / (72 x SCr)} x 0.85 (if female). * Urine dipstick protein \< 1 + (30 - 70 mg/dL), urine protein/creatinine ratio of \< 1, OR 24 hour urine protein \< 1g/24 hours.
• Have acceptable bone marrow function defined as: * Absolute neutrophil count ≥ 1,500 cells / mm3. * Platelet count ≥ 100,000 cells / mm3 (unsupported, no transfusion within 7 days of enrollment). * Hemoglobin \> 9.0 g/dL (unsupported, no transfusion within 7 days of enrollment).
• Have acceptable coagulation parameters (anti-coagulation allowed) defined as: * International normalized ratio ≤ 2 x ULN unless on anticoagulation or prothrombin time within normal limits. * Activated partial thromboplastin time within normal limits.
• Have a negative serum pregnancy test result at screening (females of childbearing potential \[FCBP\] only). Not applicable to participants who are surgically sterile (i.e., bilateral salpingectomy, bilateral oophorectomy, or complete hysterectomy) or who are post-menopausal. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.
• Contraceptive use by men and women must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. FCBP whose partner(s) are non-sterilized males and non-sterilized male participants whose sexual partner(s) are FCBP must abstain from heterosexual activity or agree to use an acceptable method of contraception according to the following guidelines: * The reliability of sexual abstinence for male and/or female enrollment eligibility needs to be evaluated in relation to the duration of the entire period of risk associated with study interventions and the preferred and usual lifestyle of the participant. Total sexual abstinence is an acceptable method provided it is the usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post ovulation methods), the rhythm method, and withdrawal are not acceptable methods of contraception. * Non-sterilized Male Participants: * Must use an acceptable method of contraception such as male condom plus spermicide during the entire period of risk associated with study interventions which includes the total duration of the study and the drug washout period (6 months after the last dose of study intervention) and refrain from sperm donation or banking throughout this period. * Vasectomized males are considered fertile and should still use a male condom plus spermicide as indicated above. * Even if the female partner is pregnant, male participants should still use a condom plus spermicide, as indicated above.. * Female partners (of childbearing potential) of male participants must also use a highly effective method of contraception during the entire period of risk associated with study interventions as described above. * FCBP * Must use a highly effective method of contraception and avoid breastfeeding during the entire period of risk associated with study interventions which includes the total duration of the study and the drug washout period (9 months after the last dose of study intervention) and refrain from egg donation or banking throughout this period. * Non-sterilized male partners must also use a male condom plus spermicide during the entire period of risk associated with study interventions as described above. * A highly effective method of contraception is defined as one that results in a low failure rate (less than 1% per year) when used consistently and correctly. Note that some contraception methods are not considered highly effective. The participants chosen method(s) must be confirmed as highly effective prior to study entry.
• Participant is capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion Criteria:

Participants must not meet any of the following criteria:
• Have locally confirmed DNA-mismatch repair deficient or microsatellite instability (MSI) status - high Stage IV colorectal cancer.
• Participants with brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry, have no evidence of new or enlarging brain metastases and are off steroids for at least 7 days.
• Have a concurrent malignancy or have had another malignancy within the past 5 years prior to screening that is expected to alter life expectancy or may interfere with disease assessment.
• Have Type 1 or 2 diabetes mellitus.
• Have Reversible Posterior Leukoencephalopathy.
• Have a history of or evidence of active gastrointestinal perforation or gastrointestinal fistula.
• Have a family history of a genetic / familial neuropathy.
• Have pre-existing clinical neuropathy ≥ Grade 2 per CTCAE v5.0 from any cause.
• Have had major surgery other than a minor outpatient procedure within 28 days prior to randomization or have not recovered from major side effects of the surgery if more than 4 weeks have elapsed since surgery.
• Have poorly controlled hypertension despite the use of antihypertensive agents defined as blood pressure \> 150/90 mmHg on at least 2 repeated determinations on separate days during screening period.
• Have a history of cardiac dysfunction including: * Myocardial infarction within 6 months prior to initiation of screening. * History of documented congestive heart failure (New York Heart Association functional classification III-IV) within 6 months prior to initiation of screening * Active cardiomyopathy. * Electrocardiogram with QTc \> 470 milliseconds at screening.
• Have uncontrolled severe infections (acute or chronic) including HIV, Hepatitis B or C
• Have active poor wound healing (delayed healing, wound infection or fistula).
• Have evidence of active, clinically significant bleeding (e.g., gastrointestinal bleeding, hemoptysis, or gross hematuria) at screening. No bleeding diathesis, hemorrhage, or arterial/ venous thrombotic events within 6 months prior to initiation of screening, including transient ischemic attack, cerebrovascular accident, unstable angina or angina requiring surgical or medical intervention in the past 6 months, or myocardial infarction. Patients with clinically significant peripheral artery disease (i.e., claudication on less than one block) or any other arterial thrombotic event are also ineligible.
• Are breast feeding or pregnant, confirmed by a positive serum human chorionic gonadotropin (hCG) laboratory test.
• Have other concurrent severe and/or uncontrolled medical condition that would, in the Investigator's judgment contraindicate the participant's participation in the clinical study or obscure proper assessment of safety and toxicity of the prescribed regimen.
• Have received prior treatment with any investigational drug within 4 weeks (28 days) prior to randomization.
• Have received prior treatment with neurotoxic chemotherapy including but not limited to oxaliplatin, cisplatin, a taxane, or a vinca alkaloid.
• Have received prior treatment with any anti-VEGF agent.
• Are receiving any agent for the treatment, prevention, or with known/hypothesized efficacy for peripheral neuropathy; including but not limited to gabapentin, pregabalin, venlafaxine, duloxetine, amitriptyline, nortriptyline, or anti-neuropathic pain topical cream.
• Have a known sensitivity to the components of BXQ-350 (SapC and DOPS).

Interventions: DRUG: BXQ-350, OTHER: Placebo

Conditions: Metastatic Colorectal Carcinoma, Neuropathy

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Phase 1/2 Study of BDTX-1535 in Patients With Glioblastoma or Non-Small Cell Lung Cancer With EGFR Mutations

Contact(s):

Lisa Johnson - Lisa.Johnson@prismahealth.org

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 18 years and over

Phase: PHASE1

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT05256290

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Phase 2 Eligibility: Key Inclusion Criteria Required for locally advanced or metastatic NSCLC: * Measurable disease by RECIST 1.1 criteria. * Adequate bone marrow or organ function. * Life expectancy of ≥ 3 months. * Sufficient performance status. * Confirmed NSCLC, without small cell lung cancer transformation with or without brain metastases. * Disease progression following or intolerance of standard of care (excluding patients in the treatment-naïve non-classical driver cohort): * Cohort 1 (Non-Classical driver cohort): Advanced/metastatic NSCLC with a non-classical driver EGFR mutation (eg, G719X) following up to 2 lines of therapy with only 1 prior EGFR TKI regimen (third-generation preferred; other approved EGFR TKI acceptable). * Cohort 2 (Acquired resistance C797S cohort): Advanced/metastatic NSCLC with the acquired resistance C797S EGFR mutation following up to 2 lines of therapy, including only one EGFR TKI, which must be a third generation EGFR TKI (eg, osimertinib). * Cohort 3 (First-line non-classical driver cohort): Treatment-naïve advanced/metastatic NSCLC with a non-classical driver EGFR mutation (1 cycle of chemotherapy or immune checkpoint inhibitor are permitted). Patients with co-occurring L858R mutations and a non-classical mutation are eligible for inclusion. * Identification of one (or more) of the following EGFR mutations by Next Generation Sequencing (NGS) as determined by a local assay performed in a validated laboratory in the absence of other known resistance mutations (eg, T790M, MET): * Non-classical driver EGFR mutations (eg, L861R, S768I, G719X). * EGFR acquired resistance mutation (eg, C797S) to a 3rd generation EGFR TKI. * For Phase 2, dose expansion, patients in Cohort 1 who received 3rd generation EGFR TKI (eg, osimertinib), the NGS report within 6 months prior to the start of Screening is acceptable. For patients in Cohort 2, the NGS report must be from the last disease progression on the immediate prior therapy. For patients in Cohort 3, the NGS report must be at the time of diagnosis. Key

Exclusion Criteria:

* Known resistant mutations in tumor tissue or by liquid biopsy (eg, T790M, MET). * Received more than 1 EGFR TKI therapy (ie, erlotinib or gefitinib) for the treatment of metastatic or recurrent EGFR NSCLC. * Any history of interstitial lung disease related to EGFR TKI use. * Symptomatic or radiographic leptomeningeal disease. * Symptomatic brain metastases or spinal cord compression requiring urgent clinical intervention. * Unresolved toxicity from prior therapy. * Significant cardiovascular disease. * Major surgery within 4 weeks of study entry or planned during study. * Ongoing or recent anticancer therapy or radiation therapy. * Evidence of malignancy (other than study-specific malignancies) requiring active therapy within the next 2 years. * Active hepatitis B or C infection and/or known human immunodeficiency virus (HIV) carrier. * Poorly controlled gastrointestinal disorders.

Interventions: DRUG: BDTX-1535 monotherapy

Conditions: Non-Small Cell Lung Cancer, Advanced Non-Small Cell Squamous Lung Cancer, Metastatic Lung Non-Small Cell Carcinoma, Metastatic Lung Cancer, NSCLC, Advanced Lung Carcinoma, Epidermal Growth Factor Receptor C797S, Epidermal Growth Factor Receptor G719X, EGF-R Positive Non-Small Cell Lung Cancer, EGFR-TKI Resistant Mutation

Keywords: EGFR alterations, EGFR L858R, EGFR Exon 19 del, EGFR inhibitor, intrinsic resistance NSCLC EGFR, acquired resistance NSCLC EGFR, intracranial disease, brain metastases, central nervous system metastases, CNS metastases, uncommon NSCLC EGFR mutations, C797S acquired resistance EGFR mutation, non-classical NSCLC EGFR mutations, classical NSCLC EGFR mutations, EGFR PACC NSCLC mutations, EGFR E709A/G/K/Q/V, EGFR E709_T710delinsD/T, EGFR G719A/C/D/R/S, EGFR G724S, EGFR L718Q/V, EGFR L747S/P, L747_A750delinsP, L747_P753delinsS, Second-site EGFR mutation

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Phase II Study of Tazemetostat in Solid Tumors Harboring an ARID1A Mutation

Contact(s):

Lisa M Johnson, RN - lisa.johnson@prismahealth.org

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 18 years and over

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT05023655

Show full eligibility criteria

Inclusion Criteria:

* Have voluntarily agreed to provide written informed consent and demonstrated willingness and ability to comply with all aspects of the protocol. * Histologically and/or cytologically confirmed advanced or metastatic solid tumor harboring ARID1A mutation (except epithelioid sarcoma) * Progression of disease following approved therapies or for which no standard therapy exists * For subjects who have experienced any clinically significant toxicity related to a prior anticancer treatment (i.e., chemotherapy, immunotherapy, and/or radiotherapy): at the time the subject provides voluntary written informed consent, all toxicities have either resolved to grade 1 per NCI CTCAE Version 5.0 \[11\] OR are clinically stable and no longer clinically significant. * Have measurable disease as defined by RECIST 1.1. * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. * Males or females are \>18 years of age at the time of providing voluntary written informed consent. * Life expectancy \>3 months before enrollment. * Time between prior anticancer therapy and first dose of tazemetostat as follows: Cytotoxic chemotherapy - At least 21 days Noncytotoxic chemotherapy (e.g., small molecule inhibitor) - At least 14 days. Nitrosoureas - At least 6 weeks. Monoclonal antibody - At least 28 days. Radiotherapy - At least 14 days. In addition, at least 6 weeks from prior radioisotope therapy; and at least 12 weeks from 50% pelvic or total body irradiation. * Adequate renal function: Creatinine \< 2.0 or calculated creatinine clearance ≥ 35 mL/minute per the Cockcroft and Gault formula * Adequate bone marrow function: ANC ≥ 750mm3 without growth factor support (filgrastim or pegfilgrastim) for at least 14 days. Platelets ≥ 75,000mm3 (≥75 × 109/L) evaluated at least 7 days after platelet transfusion. Hemoglobin ≥9.0 g/dL and may receive transfusion Adequate liver function: Total bilirubin \<1.5 × the upper limit of normal (ULN) (except for unconjugated hyperbilirubinemia of Gilbert's syndrome); Alkaline phosphatase (ALP) (in the absence of bone disease), ALT, and AST \<3 × ULN (or \<5 × ULN if subject has liver metastases).

Exclusion Criteria:

* Subjects with epithelioid sarcoma are excluded. * Has a prior history of T-Cell Lymphoblastic Lymphoma, T-Cell Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Myeloproliferative Neoplasm. * Female subjects who are pregnant or breastfeeding. * Prior exposure to tazemetostat or other inhibitor(s) of EZH2. * Subjects with uncontrolled CNS metastases requiring steroids. * Subjects taking medications that are known potent CYP3A4 inducers/inhibitors (including St. John's wort) * Are unwilling to exclude Seville oranges, grapefruit juice, AND grapefruit from their diet. * Major surgery within 4 weeks before the first dose of study drug. NOTE: Minor surgery (e.g., minor biopsy of extracranial site, central venous catheter placement, shunt revision) is permitted within 1 week prior to enrollment. * Are unable to take oral medication OR have malabsorption syndrome or any other uncontrolled gastrointestinal condition (e.g., nausea, diarrhea, vomiting) that might impair the bioavailability of tazemetostat. * Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II (Appendix 3), uncontrolled arterial hypertension, unstable angina, myocardial infarction, or stroke within 6 months of the first dose of study drug; or cardiac ventricular arrhythmia. * Have an active infection requiring systemic therapy. * Known hypersensitivity to any component of tazemetostat. * Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the subject's participation in this study OR interfere with their ability to receive study treatment or complete the study. * Subjects who have undergone a solid organ transplant. * Prior malignancy in the past 5 years.

Interventions: DRUG: Tazemetostat

Conditions: Solid Tumor, ARID1A Gene Mutation

Keywords: ARID1A mutation, solid tumors, tazemetostat

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LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF (LEVEL)

Contact(s):

Kevin Crawford - k.crawford@tenaxthera.com

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 18 years to 85 years old

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT05983250

Show full eligibility criteria

Interventions: DRUG: TNX-103, DRUG: Placebo

Conditions: Pulmonary Hypertension

Keywords: HFpEF, Pulmonary hypertension group 2, PH-HFpEF

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Search Results

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Electrical DN as an Adjunct to Eccentric Exercise, Stretching + MT for Achilles Tendinopathy

Genetic Testing in Screening Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (The ALCHEMIST Screening Trial)

BXQ-350 in Newly Diagnosed Metastatic Colorectal Carcinoma (ASIST)

Phase 1/2 Study of BDTX-1535 in Patients With Glioblastoma or Non-Small Cell Lung Cancer With EGFR Mutations

Phase II Study of Tazemetostat in Solid Tumors Harboring an ARID1A Mutation

LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF (LEVEL)

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