Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003348
Status:
COMPLETED
Last Update Posted:
2013-02-20
First Post:
1999-11-01
Brief Title:
Carmustine Plus O6-Benzylguanine in Treating Patients With Recurrent or Progressive Gliomas of the Brain
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Phase I Trial of BCNU Plus O6-Benzylguanine in the Treatment of Patients With Recurrent Persistent 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 I trial to study the effectiveness of carmustine plus O6-benzylguanine in treating patients who have recurrent or progressive gliomas of the brain
PURPOSE Phase I trial to study the effectiveness of carmustine plus O6-benzylguanine in treating patients who have recurrent or progressive gliomas of the brain
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of carmustine when administered following O6-benzylguanine in patients with recurrent persistent or progressive cerebral anaplastic gliomas II Characterize the toxic effects associated with this treatment regimen in these patients III Observe patients for clinical antitumor response when treated with this regimen
OUTLINE Patients are stratified according to prior nitrosourea administration yes or no Prior nitrosoureas stratum closed An initial cohort of 3 patients per stratum is treated with intravenous O6-benzylguanine followed approximately 1 hour later by intravenous carmustine every 6 weeks Additional cohorts of 3-6 patients are treated with escalating doses of carmustine until dose limiting toxicity DLT is observed The maximum tolerated dose is defined as the dose at which no more than 1 of 6 patients experiences DLT Courses are repeated every 6 weeks in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 24-56 patients 12-28 per stratum will be accrued in 12 months
OUTLINE Patients are stratified according to prior nitrosourea administration yes or no Prior nitrosoureas stratum closed An initial cohort of 3 patients per stratum is treated with intravenous O6-benzylguanine followed approximately 1 hour later by intravenous carmustine every 6 weeks Additional cohorts of 3-6 patients are treated with escalating doses of carmustine until dose limiting toxicity DLT is observed The maximum tolerated dose is defined as the dose at which no more than 1 of 6 patients experiences DLT Courses are repeated every 6 weeks in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 24-56 patients 12-28 per stratum will be accrued in 12 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 |
|---|---|---|---|
| NCI-T94-0080 | None | None | None |
| DUMC-1094-99-6R5 | None | None | None |
| DUMC-929-97-6R3 | None | None | None |
| DUMC-980-98-6R4 | None | None | None |