Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00046878
Status:
WITHDRAWN
Last Update Posted:
2013-03-28
First Post:
2002-10-03
Brief Title:
Carmustine and O6-Benzylguanine in Treating Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Phase 2 Trial of BCNU Plus O6-Benzylguanine NSC 637037 in the Treatment of Patients With Newly Diagnosed Glioblastoma Multiforme
Status:
WITHDRAWN
Status Verified Date:
2013-03
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die O6-benzylguanine may increase the effectiveness of carmustine by making tumor cells more sensitive to the drug
PURPOSE Phase II trial to study the effectiveness of combining carmustine with O6-benzylguanine in treating patients who have newly diagnosed supratentorial glioblastoma multiforme
PURPOSE Phase II trial to study the effectiveness of combining carmustine with O6-benzylguanine in treating patients who have newly diagnosed supratentorial glioblastoma multiforme
Detailed Description:
OBJECTIVES
Determine the activity of carmustine and O6-benzylguanine in patients with newly diagnosed supratentorial glioblastoma multiforme not requiring immediate radiotherapy
Determine the toxicity of this regimen in these patients
OUTLINE Patients receive O6-benzylguanine IV over 1 hour followed approximately 1 hour later by carmustine IV over 1 hour on day 1 Treatment repeats every 6 weeks for a maximum of 3 courses in the absence of disease progression or unacceptable toxicity Patients are then referred for radiotherapy Patients who demonstrate tumor response after completion of the third course of chemotherapy receive 6 additional courses after completion of radiotherapy
PROJECTED ACCRUAL A total of 19-36 patients will be accrued for this study
Determine the activity of carmustine and O6-benzylguanine in patients with newly diagnosed supratentorial glioblastoma multiforme not requiring immediate radiotherapy
Determine the toxicity of this regimen in these patients
OUTLINE Patients receive O6-benzylguanine IV over 1 hour followed approximately 1 hour later by carmustine IV over 1 hour on day 1 Treatment repeats every 6 weeks for a maximum of 3 courses in the absence of disease progression or unacceptable toxicity Patients are then referred for radiotherapy Patients who demonstrate tumor response after completion of the third course of chemotherapy receive 6 additional courses after completion of radiotherapy
PROJECTED ACCRUAL A total of 19-36 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 |
|---|---|---|---|
| CDR0000256332 | OTHER | NCI | None |
| DUMC-3318-01-12 | None | None | None |
| NCI-5632 | None | None | None |