Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004028
Status:
COMPLETED
Last Update Posted:
2009-02-09
First Post:
1999-12-10
Brief Title:
Carmustine in Treating Patients With Recurrent Malignant Glioma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
PHASE I OPEN LABEL MULTICENTER DOSE ESCALATION STUDY OF GLIADEL IN PATIENTS WITH RECURRENT MALIGNANT GLIOMA
Status:
COMPLETED
Status Verified Date:
1999-01
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
PURPOSE Phase I trial to study the effectiveness of carmustine in treating patients who are undergoing surgery for recurrent malignant glioma
PURPOSE Phase I trial to study the effectiveness of carmustine in treating patients who are undergoing surgery for recurrent malignant glioma
Detailed Description:
OBJECTIVES
Determine the safety of polifeprosan 20 with carmustine implant GLIADEL in patients undergoing surgery for recurrent malignant glioma
OUTLINE This is a dose escalation study
All patients undergo maximal tumor resection At the time of surgery groups of 6 patients receive up to 8 polifeprosan 20 wafers containing increasing doses of carmustine implanted into the resection cavity
Patients with an intraoperative diagnosis other than glioblastoma multiforme or anaplastic astrocytoma do not receive wafer implantation and are removed from study
Patients are followed 3 6 and 12 months after implantation
PROJECTED ACCRUAL A total of 52 patients will be accrued for this study
Determine the safety of polifeprosan 20 with carmustine implant GLIADEL in patients undergoing surgery for recurrent malignant glioma
OUTLINE This is a dose escalation study
All patients undergo maximal tumor resection At the time of surgery groups of 6 patients receive up to 8 polifeprosan 20 wafers containing increasing doses of carmustine implanted into the resection cavity
Patients with an intraoperative diagnosis other than glioblastoma multiforme or anaplastic astrocytoma do not receive wafer implantation and are removed from study
Patients are followed 3 6 and 12 months after implantation
PROJECTED ACCRUAL A total of 52 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-T96-0052H | None | None | None |
| NABTT-101-9601 | None | None | None |
| JHOC-NABTT-101-9601 | None | None | None |