Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004892
Status:
COMPLETED
Last Update Posted:
2009-02-09
First Post:
2000-03-07
Brief Title:
O6-Benzylguanine and Carmustine Implants in Treating Patients With Recurrent Malignant Glioma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I GLIADEL and Continuous Infusion of Intravenous O6-Benzylguanine Trial in Patients With Recurrent Malignant Glioma
Status:
COMPLETED
Status Verified Date:
2007-02
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 and giving drugs in different ways may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of O6-benzylguanine and implanted carmustine wafers in treating patients who have recurrent malignant glioma
PURPOSE Phase I trial to study the effectiveness of O6-benzylguanine and implanted carmustine wafers in treating patients who have recurrent malignant glioma
Detailed Description:
OBJECTIVES I Determine the dose of O6-benzylguanine that completely suppresses AGT levels in patients with recurrent malignant glioma II Evaluate the safety and tolerance of increasing duration for up to 2 weeks of continuously infused O6-benzylguanine at a dose that will completely suppress tumor AGT activity combined with intracranially implanted polifeprosan 20 with carmustine implants Gliadel wafers in this patient population
OUTLINE This is a dose escalation study of O6-benzylguanine O6-BG Patients in the first cohort receive O6-BG IV over 1 hour followed by continuous infusion of O6-BG for 2 days prior to surgery Patients undergo surgical resection and receive up to 8 polifeprosan 20 with carmustine implants Gliadel wafers in the resected tumor cavity Cohorts of 14 patients receive escalating doses of O6-BG until 11 out of 14 patients in a cohort have complete suppression of AGT levels Once the dose of O6-BG that completely suppresses AGT has been established subsequent patients receive O6-BG IV beginning at least 1 hour prior to surgery followed by the established continuous infusion dose beginning on the day of surgery The infusion continues for up to 14 days postoperatively Cohorts of 6-12 patients receive lengthened durations of continuous infusion O6-BG until the maximum tolerated dose MTD is determined or the length of the infusion reaches 14 days The MTD is defined as the dose preceding that at which 3 of 6 or 5 of 12 patients experience dose limiting toxicities Patients are followed at 3 6 9 and 12 months and then until death
PROJECTED ACCRUAL A minimum of 38 patients will be accrued for this study over 95 months
OUTLINE This is a dose escalation study of O6-benzylguanine O6-BG Patients in the first cohort receive O6-BG IV over 1 hour followed by continuous infusion of O6-BG for 2 days prior to surgery Patients undergo surgical resection and receive up to 8 polifeprosan 20 with carmustine implants Gliadel wafers in the resected tumor cavity Cohorts of 14 patients receive escalating doses of O6-BG until 11 out of 14 patients in a cohort have complete suppression of AGT levels Once the dose of O6-BG that completely suppresses AGT has been established subsequent patients receive O6-BG IV beginning at least 1 hour prior to surgery followed by the established continuous infusion dose beginning on the day of surgery The infusion continues for up to 14 days postoperatively Cohorts of 6-12 patients receive lengthened durations of continuous infusion O6-BG until the maximum tolerated dose MTD is determined or the length of the infusion reaches 14 days The MTD is defined as the dose preceding that at which 3 of 6 or 5 of 12 patients experience dose limiting toxicities Patients are followed at 3 6 9 and 12 months and then until death
PROJECTED ACCRUAL A minimum of 38 patients will be accrued for this study over 95 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 |
|---|---|---|---|
| JHOC-NABTT-9803 | None | None | None |
| NABTT-9803 | None | None | None |