A Phase II Safety Study of Bevacizumab in Patients With Multiple Recurrent or Progressive Malignant Gliomas
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Northwestern University
- Enrollment
- 55
- Locations
- 4
- Primary Endpoint
- Progression-free Survival at 6 Months
Study Overview
Brief Summary
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.
Detailed Description
OBJECTIVES:
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Progression-free Survival at 6 Months
Time Frame: After all patients have surpassed the 6 month post-treatment timepoint
The number of patients experiencing progression free survival (PFS) was calculated at the 6-month time point.
Safety of Treatment
Time Frame: From treatment initiation, throughout treatment and up to 30 days post-treatment, for up to 1 year.
Safety of treatment will be defined by the number of patients that experience grade 3 and 4 adverse events where causal relationship with bevacizumab cannot be completely ruled out. Adverse events will be graded using Common Terminology Criteria for Adverse Events v3.0 (CTCAE) where: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE
Tumoral Blood Flow Changes
Time Frame: Before and after treatment
To assess changes in tumoral blood flow based on MR Perfusion and tissue changes by MR spectroscopy.
Secondary Outcomes
No secondary outcomes reported
Investigators
Jeffrey Raizer
Jeffrey Raizer, MD
Northwestern University