Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-28 @ 1:53 AM
Study NCT ID:
NCT00003467
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Carmustine in Treating Adults With Recurrent Supratentorial Low-Grade Glioma
Sponsor:
Duke University
Organization:
Study Overview
Official Title:
Phase II Treatment of Adults With Recurrent Supratentorial Low Grade Glioma With Gliadel Wafers
Status:
COMPLETED
Status Verified Date:
2009-10
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 II trial to study the effectiveness of carmustine in treating adults with recurrent supratentorial low-grade glioma.
PURPOSE: Phase II trial to study the effectiveness of carmustine in treating adults with recurrent supratentorial low-grade glioma.
Detailed Description:
OBJECTIVES:
* Determine the antitumor activity of Gliadel wafers (carmustine) in the treatment of recurrent supratentorial low grade glioma.
* Assess the toxicity of this therapy in these patients.
OUTLINE: Patients are stratified by disease (fibrillary astrocytoma vs oligodendroglioma or mixed glioma).
Patients receive up to 8 Gliadel wafers (containing carmustine) implanted in the resected tumor cavity.
Patients are followed every 2 months.
PROJECTED ACCRUAL: This study will accrue a maximum of 68 patients within 18-24 months.
* Determine the antitumor activity of Gliadel wafers (carmustine) in the treatment of recurrent supratentorial low grade glioma.
* Assess the toxicity of this therapy in these patients.
OUTLINE: Patients are stratified by disease (fibrillary astrocytoma vs oligodendroglioma or mixed glioma).
Patients receive up to 8 Gliadel wafers (containing carmustine) implanted in the resected tumor cavity.
Patients are followed every 2 months.
PROJECTED ACCRUAL: This study will accrue a maximum of 68 patients within 18-24 months.
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 ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| DUMC-1706-02-9R5 | None | None | View | |
| DUMC-1706-01-9R4 | None | None | View | |
| DUMC-000693-00-4 | None | None | View | |
| DUMC-1509-97-10 | None | None | View | |
| DUMC-1568-98-10R1 | None | None | View | |
| DUMC-1706-00-9R3 | None | None | View | |
| DUMC-97131 | None | None | View | |
| NCI-G98-1470 | None | None | View | |
| CDR0000066503 | OTHER | NCI | View |