Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00352521
Status:
COMPLETED
Last Update Posted:
2014-07-22
First Post:
2006-07-13
Brief Title:
Dynamic Contrast-Enhanced Magnetic Resonance Imaging DCE-MRI With Bevacizumab and Irinotecan for Malignant Glioma
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Dynamic Contrast-Enhanced Magnetic Resonance Imaging With 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 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 patients 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
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
Detailed Description:
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
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
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 |
|---|---|---|---|
| CDR0000481476 | OTHER | NCI | None |
| DUMC-8053-05-12R0 | None | None | None |