Brain and Central Nervous System Tumors Clinical Trial
Official title:
A Phase II Safety Study of Bevacizumab in Patients With Multiple Recurrent or Progressive Malignant 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.
PURPOSE: This phase II trial is studying how well bevacizumab works in treating patients with
recurrent or progressive glioma.
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.
PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.
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