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| Sponsors and Collaborators: |
Duke University National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003467 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: carmustine Drug: polifeprosan 20 with carmustine implant Procedure: surgical procedure |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase II Treatment of Adults With Recurrent Supratentorial Low Grade Glioma With Gliadel Wafers |
| Estimated Enrollment: | 68 |
| Study Start Date: | January 1998 |
OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed recurrent primary low grade glioma including:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, North Carolina | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| Study Chair: | Henry S. Friedman, MD | Duke University |
More Information
| Study ID Numbers: | CDR0000066503, DUMC-1706-02-9R5, DUMC-1706-01-9R4, DUMC-000693-00-4, DUMC-1509-97-10, DUMC-1568-98-10R1, DUMC-1706-00-9R3, DUMC-97131, NCI-G98-1470 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003467 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent adult brain tumor adult brain stem glioma adult mixed glioma |
adult anaplastic astrocytoma adult pilocytic astrocytoma adult oligodendroglioma |
|
Astrocytoma Carmustine Central Nervous System Neoplasms Recurrence Brain Neoplasms Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neuroepithelioma Oligodendroglioma Glioma Antineoplastic Agents, Alkylating Alkylating Agents Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
|
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Nervous System Diseases Carmustine Central Nervous System Neoplasms Pharmacologic Actions Neuroectodermal Tumors Neoplasms |
Neoplasms by Site Therapeutic Uses Neoplasms, Germ Cell and Embryonal Antineoplastic Agents, Alkylating Glioma Neoplasms, Neuroepithelial Alkylating Agents Nervous System Neoplasms Neoplasms, Glandular and Epithelial |