Glioma Clinical Trial
Official title:
Phase II Study of Bevacizumab (Avastin) and BCNU for Treatment of Relapsed, High Grade Gliomas
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. Drugs used in chemotherapy, such
as carmustine, work in different ways to stop the growth of tumor cells, either by killing
the cells or by stopping them from dividing. Giving bevacizumab together with carmustine may
kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with carmustine
works in treating patients with relapsed or progressive high-grade glioma.
OBJECTIVES:
Primary
- To determine the 6-month progression-free survival of patients with relapsed or
progressive high-grade gliomas treated with bevacizumab and carmustine.
Secondary
- 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.
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