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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
Bevacizumab 15 mg/kg every 3 weeks over 30 to 90 minutes. One cycle = 3 weeks. Treatment continues until progressive disease or unacceptable toxicity.
Hematology-Oncology Associates of Illinois
Chicago, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States
Safety of Treatment
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
Time frame: From treatment initiation, throughout treatment and up to 30 days post-treatment, for up to 1 year.
Progression-free Survival at 6 Months
The number of patients experiencing progression free survival (PFS) was calculated at the 6-month time point.
Time frame: After all patients have surpassed the 6 month post-treatment timepoint
Tumoral Blood Flow Changes
To assess changes in tumoral blood flow based on MR Perfusion and tissue changes by MR spectroscopy.
Time frame: Before and after treatment
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