Brain and Central Nervous System Tumors Clinical Trial
Official title:
Dynamic Contrast-Enhanced Magnetic Resonance Imaging With Bevacizumab in Combination With Irinotecan for 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 block blood
flow to the tumor. Drugs used in chemotherapy, such as irinotecan, 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 irinotecan may kill more tumor cells. Diagnostic
procedures, such as MRI, may help doctors predict a patient's response to treatment and help
plan the best treatment.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with
irinotecan works in treating patients with recurrent malignant glioma and how well MRI
predicts response to treatment.
OBJECTIVES:
Primary
- Examine the effect of bevacizumab and irinotecan on vascular permeability and blood
flow in patients with recurrent malignant gliomas.
Secondary
- Determine the reproducibility of dynamic contrast-enhanced (DCE-MRI) in malignant
gliomas.
- Determine the predictive value of DCE-MRI in patients with recurrent malignant gliomas
treated with bevacizumab and irinotecan.
- Describe the activity of the combination of bevacizumab with irinotecan as measured by
response rate and progression-free survival.
- Describe the toxicity associated with the administration of bevacizumab with
irinotecan.
OUTLINE: Patients receive bevacizumab IV on days 1, 15, and 29 and irinotecan IV on days 2,
15, and 29 during the first 6-week cycle. After the first cycle, the irinotecan and
bevacizumab will be given on days 1, 15 and 29. Courses repeat every 6 weeks in the absence
of disease progression or unacceptable toxicity.
Patients also undergo dynamic contrast-enhanced MRI 4 times.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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