Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005081
Status:
COMPLETED
Last Update Posted:
2014-08-21
First Post:
2000-04-06
Brief Title:
Carmustine Plus O6-benzylguanine in Treating Patients With Recurrent or Progressive Glioma
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Phase II Trial of BCNU Plus O6-Benzylguanine in the Treatment of Patients With Recurrent or Progressive Cerebral Anaplastic 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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining carmustine and O6-benzylguanine in treating patients who have recurrent or progressive glioma
PURPOSE Phase II trial to study the effectiveness of combining carmustine and O6-benzylguanine in treating patients who have recurrent or progressive glioma
Detailed Description:
OBJECTIVES I Determine the activity of carmustine and O6-benzylguanine in patients with recurrent or progressive glioblastoma multiforme anaplastic astrocytoma or gliosarcoma resistant to nitrosourea II Determine the toxic effects of this regimen in these patients
OUTLINE Patients receive O6-benzylguanine IV over 1 hour followed 1 hour later by carmustine IV over 1 hour on day 1 Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 18-32 patients will be accrued for this study within 12-18 months
OUTLINE Patients receive O6-benzylguanine IV over 1 hour followed 1 hour later by carmustine IV over 1 hour on day 1 Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 18-32 patients will be accrued for this study within 12-18 months
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 |
|---|---|---|---|
| CDR0000067688 | None | None | None |
| DUMC-0059-00-1 | None | None | None |
| DUMC-T98-0059 | None | None | None |
| NCI-T98-0059 | None | None | None |