Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2026-01-02 @ 1:18 PM
Study NCT ID:
NCT00268359
Status:
COMPLETED
Last Update Posted:
2014-07-21
First Post:
2005-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bevacizumab and Irinotecan in Treating Patients With Recurrent or Refractory Gliomas
Sponsor:
Duke University
Organization:
Study Overview
Official Title:
Bevacizumab in Combination With Irinotecan for Malignant Gliomas
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
OBJECTIVES:
Primary
* Determine the safety of bevacizumab and irinotecan hydrochloride in patients with recurrent or refractory grade 3 or 4 malignant gliomas.
Secondary
* 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.
Primary
* Determine the safety of bevacizumab and irinotecan hydrochloride in patients with recurrent or refractory grade 3 or 4 malignant gliomas.
Secondary
* 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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: