Phase II Study of Bevacizumab (Avastin) and BCNU for Treatment of Relapsed, High Grade Gliomas
- To determine the 6-month progression-free survival of patients with relapsed or
progressive high-grade gliomas treated with bevacizumab and carmustine.
- To evaluate the radiographic response to this regimen as measured by MRI and PET scan
with image fusion.
- To utilize novel brain imaging to differentiate between a radiographic response due to
tumor shrinkage and a radiographic response due to decreased vasogenic edema.
- To evaluate the safety and toxicity of this regimen in these patients.
- To evaluate the overall survival of these patients.
OUTLINE: Patients receive bevacizumab IV on days -7, 8, 22, 36, and 50 of course 1 and on
days 8, 22, 36, and 50 of all subsequent courses. Patients also receive carmustine IV over 4
hours on day 1. Treatment repeats every 56 days for up to 6 courses in the absence of
disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 3 months.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Time from first day of treatment to the first observation of disease progression or death due to any cause.
Robert T. O'Donnell, MD, PhD
University of California, Davis
United States: Institutional Review Board
|University of California Davis Cancer Center||Sacramento, California 95817|