Dynamic Contrast-Enhanced Magnetic Resonance Imaging With Bevacizumab in Combination With Irinotecan for Malignant Gliomas
- Examine the effect of bevacizumab and irinotecan on vascular permeability and blood
flow in patients with recurrent malignant gliomas.
- Determine the reproducibility of dynamic contrast-enhanced (DCE-MRI) in malignant
- 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
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
Correlation of the acute permeability and blood flow response (24-48 hours) with progression-free survival (PFS)
Assessed by DCE-MRI
James J. Vredenburgh, MD
Duke Cancer Institute
United States: Food and Drug Administration
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|