8 studies found

T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-Positive Breast Cancer, the CompassHER2 RD Trial

PRIMARY OBJECTIVE: I. To determine if the invasive disease-free survival (iDFS) with T-DM1 and tucatinib is superior to the iDFS in the control arm (T-DM1 + placebo) when administered to high risk patients with HER2-positive breast cancer and residual disease after neoadjuvant HER2-directed therapy. SECONDARY OBJECTIVES: I. To evaluate whether...

Safety and Efficacy Study in Recurrent Grade IV Glioma

Perillyl alcohol has previously been tested in 15 clinical studies in > 600 subjects This includes 13 studies in 255 subjects using oral administration sponsored by the National Cancer Institute and two studies in > 350 subjects using intranasal administration in Brazil. NEO100 is a highly purified (>99%) form of...

Vascularized Composite Bladder Allograft Transplantation

PRIMARY OBJECTIVE: I. To perform a feasibility study of vascularized composite bladder allograft (VCBA) transplantation and demonstrate successful transplantation of a vascularized composite deceased-donor bladder allograft. SECONDARY OBJECTIVES: I. To describe the adverse events associated with VCBA transplantation. II. To describe the immunosuppression regimen for patients undergoing VCBA transplantation. III....

S1501 Carvedilol in Preventing Cardiac Toxicity in Patients With Metastatic HER-2-Positive Breast Cancer

PRIMARY OBJECTIVES: I. To assess whether prophylactic beta blocker therapy with carvedilol compared with no intervention reduces the risk of subsequent cardiac dysfunction in patients with metastatic breast cancer receiving trastuzumab?based HER-2 targeted therapy. SECONDARY OBJECTIVES: I. To assess whether prophylactic beta blocker therapy with carvedilol compared with no intervention...

Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment

PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose of temozolomide followed by selinexor in recurrent glioblastoma patients as determined by dose-limiting toxicities (DLTs) and the total toxicity profile. (Phase I) II. To evaluate the efficacy of sequentially administering temozolomide and selinexor in recurrent glioblastoma as determined by progression-free survival...

Testing if High Dose Radiation Only to the Sites of Brain Cancer Compared to Whole Brain Radiation That Avoids the Hippocampus is Better at Preventing Loss of Memory and Thinking Ability

PRIMARY OBJECTIVE: I. Determine whether stereotactic radiosurgery (SRS) relative to whole brain radiotherapy with hippocampal avoidance (HA-WBRT) plus memantine hydrochloride (memantine) for brain metastases from small cell lung cancer (SCLC) prevents cognitive function failure as measured by cognitive decline on a battery of tests: the Hopkins Verbal Learning Test -...

7T MRI Scan for the Early Detection of Melanoma Brain Metastases

PRIMARY OBJECTIVE: I. Assess the potential superiority of contrast-enhanced (CE) 7T MRI by comparing to standard of care CE 3T MRI in detecting occult brain metastases lesion at time of diagnosis of new brain metastases. SECONDARY OBJECTIVE: I. Describe the imaging characteristics of melanoma brain metastases on 7T MRI of...

SWOG S1827 (MAVERICK) Testing Whether the Use of Brain Scans Alone Instead of Brain Scans Plus Preventive Brain Radiation Affects Lifespan in Patients With Small Cell Lung Cancer

PRIMARY OBJECTIVE: I. To evaluate whether overall survival (OS) with magnetic resonance imaging (MRI) surveillance alone is not inferior to MRI surveillance combined with prophylactic cranial irradiation (PCI) for the treatment of small cell lung cancer (SCLC). SECONDARY OBJECTIVES: I. To compare cognitive failure free survival (CFFS) rate up to...