Bevacizumab and Temozolomide in Treating Older Patients With Newly-Diagnosed Glioblastoma Multiforme or Gliosarcoma
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Giant Cell Glioblastoma
- Glioblastoma
- Gliosarcoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 70 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. To estimate overall survival in elderly subjects treated with bevacizumab and temozolomide for newly diagnosed glioblastoma multiforme. SECONDARY OBJECTIVES: I. To estimate 12-months survival. II. To estimate progression free survival for 2 years or until progression is detect...
PRIMARY OBJECTIVES: I. To estimate overall survival in elderly subjects treated with bevacizumab and temozolomide for newly diagnosed glioblastoma multiforme. SECONDARY OBJECTIVES: I. To estimate 12-months survival. II. To estimate progression free survival for 2 years or until progression is detected. III. To investigate the safety and tolerability of bevacizumab/temozolomide in elderly patient with glioblastoma. IV. To isolate DNA, RNA, and protein isolated from frozen and paraffinized archival tumor samples for evaluations such as immunohistochemical pathway profiling of VEGF-dependent angiogenic pathways, gene expression microarray, and MGMT promoter methylation status to define important molecule features of treatment response and especially age-related molecular expression. OUTLINE: Patients receive bevacizumab IV over 30-90 minutes every 2 weeks and oral temozolomide on days 1-5. Treatment repeats every 28 days for 24 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at least every 4 months.
Tracking Information
- NCT #
- NCT01149850
- Collaborators
- Genentech, Inc.
- Investigators
- Principal Investigator: Phioanh Nghiemphu University of California at Los Angeles (UCLA )