Bevacizumab in Treating Patients With Recurrent or Progressive Glioma
RATIONALE: 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 tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well bevacizumab works in treating patients with recurrent or progressive glioma.
Brain and Central Nervous System Tumors
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Safety Study of Bevacizumab in Patients With Multiple Recurrent or Progressive Malignant Gliomas|
- Safety of Treatment [ Time Frame: Throughout treatment and up to 30 days post-treatment ] [ Designated as safety issue: Yes ]
- Progression-free Survival at 6 Months [ Time Frame: After all patients have surpassed the 6 month post-treatment timepoint ] [ Designated as safety issue: No ]The number of patients experiencing progression free survival (PFS) was calculated at the 6-month time point.
- Tumoral Blood Flow Changes [ Time Frame: Before and after treatment ] [ Designated as safety issue: No ]
|Study Start Date:||March 2006|
|Estimated Study Completion Date:||December 2016|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
Bevacizumab 15 mg/kg every 3 weeks over 30 to 90 minutes. One cycle = 3 weeks. Treatment continues until progressive disease or unacceptable toxicity.
- Determine the safety of single-agent bevacizumab in the treatment of patients with recurrent or progressive malignant glioma.
- Determine the efficacy of bevacizumab, in terms of progression-free survival at 6 months, in these patients.
- Assess changes in tumoral blood flow based on magnetic resonance (MR) perfusion and tissue changes by MR spectroscopy.
OUTLINE: This is a pilot study.
Patients receive bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00337207
|United States, Illinois|
|Hematology-Oncology Associates of Illinois|
|Chicago, Illinois, United States, 60611-2998|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University|
|Chicago, Illinois, United States, 60611-3013|
|Principal Investigator:||Jeffrey J. Raizer, MD||Robert H. Lurie Cancer Center|