Carmustine in Treating Adults With Recurrent Supratentorial Low-Grade Glioma
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|ClinicalTrials.gov Identifier: NCT00003467|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 20, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Drug: carmustine Drug: polifeprosan 20 with carmustine implant Procedure: surgical procedure||Phase 2|
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||68 participants|
|Official Title:||Phase II Treatment of Adults With Recurrent Supratentorial Low Grade Glioma With Gliadel Wafers|
|Study Start Date :||January 1998|
|Actual Study Completion Date :||February 2004|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003467
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|Study Chair:||Henry S. Friedman, MD||Duke University|