Recruitment

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 )