Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00337207
Status:
COMPLETED
Last Update Posted:
2020-02-07
First Post:
2006-06-13
Brief Title:
Bevacizumab in Treating Patients With Recurrent or Progressive Glioma
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
A Phase II Safety Study of Bevacizumab in Patients With Multiple Recurrent or Progressive Malignant Gliomas
Status:
COMPLETED
Status Verified Date:
2020-01
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
PURPOSE This phase II trial is studying how well bevacizumab works in treating patients with recurrent or progressive glioma
PURPOSE This phase II trial is studying how well bevacizumab works in treating patients with recurrent or progressive glioma
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| STU00005237 | OTHER | Northwestern University IRB | None |
| NU-05C3 | OTHER | None | None |