Bevacizumab and Irinotecan in Treating Patients With Recurrent or Refractory 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 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 tumors cells.
PURPOSE: This phase II trial is studying the side effects of bevacizumab and how well giving bevacizumab together with irinotecan works in treating patients with recurrent or refractory gliomas.
Brain and Central Nervous System Tumors
Drug: irinotecan hydrochloride
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Bevacizumab in Combination With Irinotecan for Malignant Gliomas|
- Safety [ Designated as safety issue: Yes ]
- Activity in terms of progression-free survival [ Designated as safety issue: No ]
|Study Start Date:||May 2005|
|Study Completion Date:||October 2009|
|Primary Completion Date:||August 2006 (Final data collection date for primary outcome measure)|
- Determine the safety of bevacizumab and irinotecan hydrochloride in patients with recurrent or refractory grade 3 or 4 malignant gliomas.
- Determine the activity of this regimen, in terms of progression-free survival, in these patients.
OUTLINE: Patients receive bevacizumab and irinotecan hydrochloride every 2 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 68 patients will be accrued for this study.
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|Study Chair:||James J. Vredenburgh, MD||Duke Cancer Institute|