Brain/Neuro Cancer: Recurrent Glioblastoma Clinical Trials

Showing 1-17 of 17 items
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  • PF-00299804 in Adult Patients With Relapsed/Recurrent Glioblastoma
  • There are three arms to this study (A, B and C) The purpose of this research study during Arm A is to see how much of PF-00299804 gets into the brain tumor. For many brain tumors, one reason that chemotherapy drugs might not be effective is that the drug may not be able to get into the brain tumor and kill the cancer cells. We will determine how much PF-00299804 gets into the brain tumor by obtaining a sample of the tumor from the surgery that the participant already has scheduled. The purpose of this research study during Arm B and C, is to determine how well PF-00299804 works in killing cancer cells. PF-00299804 works by binding to specific proteins found on the surface of some cancer cells that promote a growth signal. Blocking this signal from reaching its target on the cancer cells may slow or stop the cancer from growing.
  • Diagnoses: Brain/Neuro Cancer: Recurrent Glioblastoma
  • Status: Recruiting
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  • Phase Ib/II Study of Buparlisib Plus Carboplatin or Lomustine in Patients With Recurrent Glioblastoma Multiforme
  • This is a multi-center, phase Ib/ II study (two parts) with patients that have recurrent glioblastoma multiforme. The first part (phase Ib) will investigate the maximum tolerated dose/Recommended phase ll dose (MTD/RP2D) of once daily buparlisib in combination with every-three-week carboplatin or buparlisib once daily in combination with every-six-week lomustine (CCNU) using a Bayesian model. Once MTD/ RP2D is established in either of the 2 arms, the corresponding phase II portion of the study will start. Phase II will assess the treatment effect of buparlisib in combination with carboplatin in terms of Progression Free Survival (PFS) and will compare the treatment effect of buparlisib with lomustine versus lomustine plus placebo in terms of PFS.
  • Diagnoses: Brain/Neuro Cancer: Recurrent Glioblastoma
  • Status: Recruiting
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  • Amgen 386 for Recurrent Glioblastoma
  • Primary Objectives Cohort A ‐‐ monotherapy: To determine the efficacy of AMG 386 in participants with recurrent glioblastoma (GBM) as measured by 6‐month progression‐free survival (PFS6) Cohort B - combination therapy: Phase I To determine the maximum tolerated dose of AMG 386 in combination with bevacizumab given at 10mg/kg every 2 weeks in participants with recurrent glioblastoma. Phase II To determine the efficacy of AMG 386 plus bevacizumab in participants with recurrent glioblastoma (GBM) as measured by 6‐month progression‐free survival (PFS6). Secondary Objectives: To evaluate radiographic response in both cohort populations. To evaluate overall survival in both cohort populations. To assess time‐to‐progression in both cohort populations. To investigate the safety profile in both cohort populations. Exploratory Objectives: To evaluate expression of factors associated with tumor angiogenesis using a multiples cytokine assay among participants undergoing therapy with AMG 386 with response to therapy and development of resistance. This is an open‐label Phase I/II study of AMG 386 monotherapy and AMG 386 in combination with bevacizumab. Two cohorts will accrue and will be assessed sequentially. Each cohort will enroll participants with recurrent GBM. Cohort A will assess recurrent GBM participants who receive AMG 386 monotherapy at 30 g/kg every week. (Cohort A initially accrued at a dose of 15mg/kg, but this was increased to 30 mg/kg every week following an amendment). Cohort B will assess recurrent GBM participants who receive weekly AMG 386 plus bi‐weekly bevacizumab (10mg/kg). Cohort B will start with a Phase I component to determine the MTD of AMG 386 that is safe when used in combination with bevacizumab. AMG 386 is administered intravenously, and, when used in combination with intravenous bevacizumab, will be administered first. Patients will be required to come to the clinic weekly for study drug administration. For study purposes, a cycle of therapy will be 4 weeks. Treatment will continue until either evidence of progressive disease, unacceptable toxicity, non‐compliance with study follow‐up, or withdrawal of consent. The estimated rate of accrual is 60 participants per year. The estimated date of accrual completion is 1.5 years from study initiation. The estimated date of study completion will be approximately 12 months from enrollment of the last study participant.
  • Diagnoses: Brain/Neuro Cancer: Recurrent Glioblastoma
  • Status: Recruiting
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  • Plerixafor (AMD3100) and Bevacizumab for Recurrent High-Grade Glioma
  • Plerixafor in combination with bevacizumab is a drug combination that may stop cancer cells from growing abnormally. Bevacizumab, also known as Avastin, is FDA approved for use in patients with recurrent glioblastoma and has been studied extensively in other types of solid tumors. Plerixafor, also known as Mozobil, is FDA approved for use in patients with non-Hodgkin's lymphoma and multiple myeloma and has been used in treatment for other cancers. Information from experiments in laboratories suggests that the combination of plerixafor and bevacizumab may help prevent the growth of gliomas. Part 1: The investigators are looking for the highest dose of plerixafor that can be given safely with bevacizumab (with a 21 days on/7 days off regimen of plerixafor). The investigators will also do blood tests to find out how the body uses and breaks down the drug combination. Part 2: The investigators are looking to see if plerixafor can get past the blood-brain barrier and into brain tumors. The investigators will also do blood tests to find out how the body uses and breaks down the drug combination. Part 3: The investigators are looking for for more information re: safety and tolerability of plerixafor in combination with bevacizumab (with a 28 days on/0 days off regimen of plerixafor). The investigators will also do blood tests to find out how the body uses and breaks down the drug combination.
  • Diagnoses: Brain/Neuro Cancer: Recurrent Glioblastoma
  • Status: Recruiting
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  • Bevacizumab With or Without Radiation Therapy in Treating Patients With Recurrent Glioblastoma
  • This randomized phase II trial studies how well bevacizumab with or without radiation therapy works in treating patients with recurrent glioblastoma. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet know whether bevacizumab is more effective with or without radiation therapy in treating patients with recurrent glioblastoma
  • Diagnoses: Brain/Neuro Cancer: Recurrent Glioblastoma
  • Status: Recruiting
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  • AMG 595 First-in-Human in Recurrent Gliomas
  • This is an open-label, sequential dose exploration study of single agent AMG 595 administered in subjects with recurrent glioblastoma multiforme and/or anaplastic astrocytomas. This study consist of two parts. The dose exploration in Part 1, studies of cohorts of 3 subjects with recurrent Glioblastoma Multiforme (GBM) and/or Anaplastic Astrocytomas (AA) and uses a practical continuous reassessment model [CRM] to guide dose escalation and define the maximum tolerated dose (MTD). The dose expansion in Part 2 will enroll 30 subjects with GBM at a dose no higher than the MTD to further explore the safety, PK, and clinical activity of AMG 595 in this patient population. Eligible subjects enrolled in the study will receive AMG 595 beginning at study day 1. Following the first two dose of AMG 595 and upon successful completion of a 28 days window for assessing dose limiting toxicities, subject will undergo radiological assessment of their tumors with MRI during week 5. Dosing may resume at week 7 unless there is radiological evidence of progressive disease per Macdonald criteria, the subject becomes intolerant to the study medication, signs and symptoms of clinical progression are evident as determined by the investigator, or the subject withdraws consent.
  • Diagnoses: Brain/Neuro Cancer: Recurrent Glioblastoma
  • Status: Recruiting
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