7 studies in Glioblastoma Multiforme
-
Viral Therapy in Treating Patients With Recurrent Glioblastoma Multiforme
Rochester, MN
View Summary
Viral Therapy in Treating Patients With Recurrent Glioblastoma Multiforme
Location:
Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
OBJECTIVES: Primary - Determine the safety and toxicity of intratumoral and/or resection cavity administration of a recombinant, attenuated Edmonston B vaccine strain derivative of measles virus genetically engineered to produce human carcinoembryonic antigen (CEA) in patients with recurrent glioblastoma multiforme. - Determine the maximum tolerated dose of this oncolytic virus in these patients. - Determine viral gene expression at each dose level as manifested by CEA titers in patients treated with this oncolytic virus. - Assess viremia, viral replication, and measles virus shedding/persistence after intratumoral administration of this oncolytic virus. - Assess humoral and cellular immune response to the injected virus in these patients. Secondary - Determine, preliminarily, the antitumor efficacy of this vaccine in these patients. OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 2 sequential treatment groups. - Group 1 (resection cavity administration): Patients undergo en block resection of their tumor (after confirming diagnosis) on day 1, followed by recombinant measles virus encoding human carcinoembryonic antigen (MV-CEA) administered into the resection cavity over 10 minutes. - Group 2 (intratumoral and resection cavity administration): Patients undergo placement of a catheter within the tumor, followed by MV-CEA administration into the tumor through the catheter over 10 minutes on day 1. Patients undergo en block resection of their tumor with computer-assisted stereotactic techniques on day 5, followed by MV-CEA administered around the tumor bed. In both groups, cohorts of 1-6 patients receive escalating doses of MV-CEA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD in group 1 has been determined, patients are assigned to group 2. The MTD in group 1 is used to determine the starting dose in group 2. At least 10 patients are treated at the MTD determined in group 2. Biopsy specimen, resected tumor, normal tissue, and peripheral blood are collected during study for immunologic and biomarker correlative studies, including analysis of CD46 receptor levels (by immunohistochemistry [IHC]), measles virus N protein (by IHC), measles and viral gene expression and replication (by in situ hybridization), CEA monitoring (by immunoassay), measles virus N mRNA (by reverse transcriptase-polymerase chain reaction), and measles virus immunity. Assessments of immune competence and peripheral response to viral administration are also performed. After completion of study treatment, patients are followed periodically for up to 15 years. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
NCT ID:
NCT00390299IRB Number:
06-004440Who can I contact for additional information about this study?
Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
Request Information Online
-
Collecting and Storing Blood and Brain Tumor Tissue Samples From Children With Brain Tumors
Rochester, MN
View Summary
Collecting and Storing Blood and Brain Tumor Tissue Samples From Children With Brain Tumors
Location:
Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
OBJECTIVES: - Collect brain tumor tissue and an accompanying blood sample from pediatric patients with brain tumors treated at Children's Oncology Group institutions. - Provide a repository for long-term storage of specimens from these patients. - Make these specimens available to qualified researchers to understand the biology of pediatric brain tumors. OUTLINE: This is a multicenter study Brain tumor tissue and blood specimens are collected from patients and banked for future study. PROJECTED ACCRUAL: An unlimited number of specimens will be collected.
NCT ID:
NCT00919750IRB Number:
1741-05Who can I contact for additional information about this study?
Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
Request Information Online
-
Dasatinib and Bevacizumab in Treating Patients With Recurrent or Progressive High-Grade Glioma or Glioblastoma Multiforme
Jacksonville, FL
Scottsdale and Phoenix, AZ
Rochester, MN
View Summary
Dasatinib and Bevacizumab in Treating Patients With Recurrent or Progressive High-Grade Glioma or Glioblastoma Multiforme
Location:
Jacksonville, FL Scottsdale and Phoenix, AZ Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
OBJECTIVES: Primary - Determine the maximum-tolerated dose of dasatinib in combination with bevacizumab in patients with recurrent or progressive high-grade glioma or glioblastoma multiforme. (Phase I*) - Assess the safety and adverse events of this regimen in these patients. (Phase I*) - Estimate and compare the efficacy of these regimens in these patients as measured by progression-free survival at six months. (Phase II) Secondary - Describe any preliminary evidence of antitumor activity. (Phase I*) - Describe the overall toxicity associated with this regimen in these patients. (Phase I*) - Estimate and compare the efficacy of these regimens in these patients as measured by overall survival (Phase II) - Assess the impact of these regimens on the patient's quality of life using FACT-Br (no longer assessed as of 5/18/2009) (newly added as of 2/2/2010). (Phase II) - Assess the time to disease progression. (Phase II) - Assess the safety and toxicity of these regimens in this patient population. (Phase II) - Determine the relationship between tumor biomarkers and clinical outcome of patients treated with these regimens. (Phase II) (exploratory) - Assess the utility of dynamic contrast-enhanced MRI as a predictor of response to these regimens. (Phase II) (exploratory) - To assess the utility of MRI diffusion-weighted images (DWI), and specifically the apparent diffusion coefficient (ADC), as a predictor of response and survival in patients treated with bevacizumab/dasatinib combination treatment. (Phase II) (exploratory) - Bank leftover tissue for future NCCTG studies. (Phase II) (exploratory) NOTE: *Phase I completed. OUTLINE: This is a multicenter, phase I, dose-escalation study (Phase I completed) of dasatinib followed by a phase II randomized study. Patients are grouped according to study (1 vs 2). Patients in the phase II portion are stratified according to age (> 70 years of age vs ≤ 70 years of age), and ECOG performance status (0 vs 1 or 2). Phase I: Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oral dasatinib once or twice daily on days 1-14 until the maximum-tolerated dose (MTD) is determined. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. (Phase I completed) Phase II (patients are randomized to 1 of 2 treatment arms): - Arm I: Patients receive bevacizumab as in phase I and dasatinib at the MTD as determined in phase I. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. - Arm II: Patients receive bevacizumab as in phase I and oral placebo once or twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Quality of life is assessed by FACT-Br questionnaire at baseline and prior to every other course (no longer assessed as of 5/18/2009)(newly added as of 2/2/2010). Tissue samples are collected at baseline for biomarker studies and assessed by IHC, RT-PCR, and FISH. Patients undergo dynamic contrast-enhanced MRI at baseline, day 3 of course 1, and day 1 of course 2. After completion of study therapy, patients are followed up periodically for up to 3 years.
NCT ID:
NCT00892177IRB Number:
09-002385Who can I contact for additional information about this study?
Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
Request Information Online
Scottsdale: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
Jacksonville: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
-
Dasatinib or Placebo, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Jacksonville, FL
Rochester, MN
View Summary
Dasatinib or Placebo, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Location:
Jacksonville, FL Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
OBJECTIVES: - To establish a maximum-tolerated dose of dasatinib combined with radiation and temozolomide in patients with newly diagnosed glioblastoma multiforme. (Phase I) (Phase I study closed to patient accrual on April 29, 2011 and has been completed) - To determine the efficacy of dasatinib in combination with radiotherapy and concomitant adjuvant temozolomide, and compare it with the standard of care approach, consisting of radiotherapy and temozolomide, followed by adjuvant temozolomide in these patients. (Phase II) (Phase II study opened to patient accrualon August 5, 2011) - To determine the relationship between tumor biomarkers and clinical outcome of patients treated with the dasatinib/radiotherapy/temozolomide combination. (Phase II) - To evaluate potential mechanisms of therapy resistance in recurrent tumor samples obtained at the time of surgery for recurrent disease. - To assess the impact of the addition of dasatinib to radiotherapy and temozolomide on the quality of life (QOL) of these patients, as assessed by FACT-Br, EORTC QLQ-C15-PAL, and EORTC QLQ-BN20. (Phase II) - To compare the results of the two most commonly used QOL tools, FACT-Br and EORTC QLQ C15-PAL plus BN20 and validate the use of EORTC QLQ-C15-PAL plus BN20 in these patients.(Phase II) OUTLINE: This is a multicenter, phase I dose-escalation study of dasatinib (Phase I study closed to patient accrual on April 29, 2011 and has been completed) followed by a randomized phase II study (Phase II study opened to patient accrual on August 5, 2011). - Phase I: - Course 1: Patients receive oral dasatinib once daily and oral temozolomide once daily on days 1-42. Patients undergo external-beam radiotherapy (EBRT), including intensity-modulated radiotherapy, 5 days a week for 6 weeks. - Courses 2-7: Beginning 28-42 days after course 1, patients receive oral dasatinib once daily on days 1-28 and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. - Phase II: Patients are stratified according to age (> 70 years vs ≤ 70 years). Patients are randomized to 1 of 2 treatment arms. - Arm I: - Course 1: Patients receive oral dasatinib once daily and oral temozolomide once daily on days 1-42. Patients undergo EBRT 5 days a week for 6 weeks. - Courses 2-7: Beginning 28-42 days after course 1, patients receive oral dasatinib once daily on days 1-28 and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. - Arm II: - Course 1: Patients receive oral placebo once daily on days 1-42 and temozolomide as in arm I. Patients also undergo EBRT as in arm I. - Courses 2-7: Beginning 28-42 days after course 1, patients receive oral placebo once daily on days 1-28 and temozolomide as in arm I. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Tissue samples are collected for correlative studies. Quality of life is assessed periodically using the FACT-Br, EORTC QLQ-C15-PAL v.1, and EORTC BN-20 questionnaires. After completion of study therapy, patients are followed up every 6 months for 5 years.
NCT ID:
NCT00869401IRB Number:
09-001792Who can I contact for additional information about this study?
Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
Request Information Online
Jacksonville: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
-
Vorinostat, Temozolomide, or Bevacizumab in Combination With Radiation Therapy Followed by Bevacizumab and Temozolomide in Young Patients With Newly Diagnosed High-Grade Glioma
Rochester, MN
View Summary
Vorinostat, Temozolomide, or Bevacizumab in Combination With Radiation Therapy Followed by Bevacizumab and Temozolomide in Young Patients With Newly Diagnosed High-Grade Glioma
Location:
Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
PRIMARY OBJECTIVES: I. To identify the dose of vorinostat that is feasible when given in combination with radiotherapy (RT) in patients with newly diagnosed high-grade gliomas (HGG). II. To compare 1-year event-free survival of patients with newly diagnosed HGG treated with vorinostat (using MTD) versus bevacizumab versus temozolomide when given in combination with RT followed by maintenance therapy with bevacizumab and temozolomide. (Phase II) III. To compare the event-free survival of patients with newly diagnosed HGG treated with the superior chemoradiotherapy (from phase II portion) versus temozolomide given in combination with RT followed by maintenance chemotherapy with bevacizumab and temozolomide. (Phase III) SECONDARY OBJECTIVES: I. To evaluate the anti-tumor activity, as measured by event-free survival (EFS), progression-free survival (PFS), and overall survival (OS), of patients with newly diagnosed HGG treated with vorinostat, bevacizumab, or temozolomide when given in combination with RT followed by maintenance chemotherapy with bevacizumab and temozolomide. II. To define and evaluate the toxicities of each of the treatment arms of the study. III. To conduct gene expression profiling and SNP arrays in patients with newly diagnosed HGG. IV. To assess telomerase activity, hTert expression, and telomere length in patients with newly diagnosed HGG. V. To document changes in perfusion and diffusion using MR imaging at baseline, prior to, during (prior to course 3), and after maintenance therapy with bevacizumab and temozolomide. VI. To correlate functional changes in tumor with responses to bevacizumab treatment using MR diffusion/perfusion imaging. VII. To correlate the results of the bevacizumab biology studies in serum or tumor with EFS. VIII. To explore the prognostic significance of MGMT status for patients newly diagnosed with HGG treated with combined surgery, radiation, chemotherapy, and anti-angiogenic therapy. OUTLINE: This is a multicenter, feasibility, dose-escalation study of vorinostat, followed by a phase II study, followed by a phase III study. FEASIBILITY STUDY: Patients undergo 3-D conformal radiotherapy (RT) or intensity-modulated RT 5 days a week for 6 weeks. Patients also receive vorinostat orally (PO) once daily on days 1-5. Courses repeat every week for 6 weeks in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Beginning 4 weeks after completion of chemoradiotherapy, patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and temozolomide PO on days 1-5. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. PHASE II STUDY: Patients are stratified according to extent of resection (near total resection or gross total resection vs other) and histology (glioblastoma multiforme vs other). Patients are randomized to 1 of 3 treatment arms. ARM I: Patients undergo RT 5 days a week for 6 weeks and receive vorinostat at the maximum-tolerated dose determined in the feasibility study. ARM II: Patients undergo RT as in arm I and receive temozolomide PO once daily for 42 days beginning on day 5 of RT. ARM III: Patients undergo RT as in arm I and receive bevacizumab IV over 30-90 minutes on days 22 and 36. Patients in all arms receive maintenance therapy as in the feasibility study. PHASE III study: Patients are randomized to 1 of 2 treatment arms. ARM IV: Patients receive RT and temozolomide as in phase II, arm II. ARM V: Patients receive treatment as in phase II, arm I or phase II, arm III, whichever was established as the superior chemoradiotherapy arm in phase II. Patients in all arms receive maintenance therapy as in the feasibility study. Some patients undergo blood and tumor tissue sample (from surgery) collection for telomerase activity, hTert expression, telomere length, and gene expression profiling and SNP arrays analysis. After completion of study therapy, patients are followed up every 3 months for 1 year, every 6 months for 4 years, and then annually for 5 years.
NCT ID:
NCT01236560IRB Number:
11-001749Who can I contact for additional information about this study?
Rochester: Amulya A. Nageswara Rao 507-538-7623
Request Information Online
-
Bevacizumab With or Without Anti-Endoglin Monoclonal Antibody TRC105 in Treating Patients With Recurrent Glioblastoma Multiforme
Jacksonville, FL
Scottsdale and Phoenix, AZ
View Summary
Bevacizumab With or Without Anti-Endoglin Monoclonal Antibody TRC105 in Treating Patients With Recurrent Glioblastoma Multiforme
Location:
Jacksonville, FL Scottsdale and Phoenix, AZ Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
PRIMARY OBJECTIVES: I. To establish a maximum tolerated dose (MTD) of TRC105 combined with bevacizumab in this patient population. (Phase I) II. To assess the safety and adverse events of TRC105 in combination with bevacizumab in this patient population. (Phase II) III. To determine the efficacy of TRC105 in combination with bevacizumab in recurrent glioblastoma as measured by progression-free survival and compare it with the efficacy of bevacizumab alone in this patient population. (Phase II) SECONDARY OBJECTIVES: I. To assess the proportion of patients who are progression free at 6 months, treated with TRC105 in combination with bevacizumab as compared to bevacizumab alone. (Phase II) II. To assess the overall survival of patients treated with TRC105 in combination with bevacizumab compared to bevacizumab alone. (Phase II) III. To compare the impact of the treatment on the patients quality of life (QOL) using the EORTC Quality of Life QLQ-C15-PAL and QLQ-BN20 Patient Questionnaires. (Phase II) IV. To estimate patient recommendations for study participation to others using the Was It Worth It (WIWI) Questionnaire. (Phase II) TERTIARY OBJECTIVES: I. To evaluate the pharmacokinetics of TRC105. (Phase I) II. To evaluate the immunogenicity of TRC105. (Phase I) III. To determine the relationship between tumor biomarkers, circulating biomarkers of vascular response and VEGF/VEGFR SNPs in predicting efficacy and/or toxicity of treatment. (Phase II) IV. To assess the utility of MRI imaging including apparent diffusion coefficient (ADC) as a predictor of response and survival. (Phase II) V. To assess the utility of dynamic contrast enhanced (DCE) MRI as a predictor of response to bevacizumab with or without TRC105. (Phase II) OUTLINE: This is a multicenter, dose-escalation, phase I study of TRC105 followed by a randomized phase II study. Phase I: Patients receive bevacizumab intravenously (IV) over 30-90 minutes on day 1 and TRC105 IV over 1-4 hours on days 8 and 11 of course 1 and days 1 and 8 of course 2 and all subsequent courses. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Phase II: Patients are stratified according to age (> 70 vs ≤ 70) and resection at recurrence (yes vs no). Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive bevacizumab IV over 30-90 minutes on day 1 and TRC105 IV over 1-4 hours on days 8 and 11 of course 1 and days 1 and 8 of course 2 and all subsequent courses. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive bevacizumab as in arm I. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months.
NCT ID:
NCT01648348IRB Number:
12-000818Who can I contact for additional information about this study?
Rochester: Evanthia Galanis 507-538-7623
Request Information Online
-
Armodafinil in Reducing Cancer-Related Fatigue in Patients With Glioblastoma Multiforme
Scottsdale and Phoenix, AZ
Rochester, MN
View Summary
Armodafinil in Reducing Cancer-Related Fatigue in Patients With Glioblastoma Multiforme
Location:
Scottsdale and Phoenix, AZ Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
PRIMARY OBJECTIVES: I. To determine preliminary efficacy measured by patient reported fatigue (Brief Fatigue Inventory [BFI]) at 8 weeks of two doses (150mg and 250mg) of armodafinil in treating moderate fatigue compared to placebo in patients with glioblastoma. SECONDARY OBJECTIVES: I. To evaluate the tolerability at 8 weeks of 150mg and 250mg armodafinil in this patient population. II. To assess the effect of armodafinil at 8 weeks on cognitive function in patients with glioblastoma. III. To assess the impact of armodafinil on global quality of life and other fatigue endpoints (i.e. usual fatigue, activity interference) in this patient population with glioblastoma. IV. Explore the correlation between the BFI, Patient-Reported Outcomes Measurement Information System (PROMIS), and Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) measures, as well as the relationship of fatigue and cognitive difficulties. OUTLINE: Patients are randomized to 1 of 3 treatment arms. ARM I: Patients receive lower-dose armodafinil orally (PO) once daily (QD) on days 1-28. ARM II: Patients receive placebo PO QD on days 1-28. ARM III: Patients receive higher-dose armodafinil PO QD on days 1-28. In all arms, treatment repeats every 28 days for 2 courses.
NCT ID:
NCT01781468IRB Number:
12-008547
Find Mayo Clinic on