Carmustine in Treating Adults With Recurrent Supratentorial Low-Grade Glioma
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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 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: 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 |
| Study Completion Date: | February 2004 |
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.
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:
- Fibrillary astrocytoma
- Oligodendroglioma
- Mixed glioma
- Evidence of measurable enhancing or non-enhancing CNS neoplasm on MRI
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- Not specified
Hematopoietic:
- Hematocrit greater than 29%
- Absolute neutrophil count greater than 1500/mm^3
- Platelet count greater than 125,000/mm^3
Hepatic:
- SGOT less than 1.5 times upper limit of normal (ULN)
- Bilirubin less than 1.5 times ULN
Renal:
- Creatinine less than 1.5 mg/dL
- BUN less than 25 mg/dL
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 4 weeks since prior chemotherapy unless disease progression
Endocrine therapy:
- Concurrent corticosteroids allowed (must be on stable dose for 1 week prior to study)
- No concurrent immunosuppressive agents
Radiotherapy:
- At least 4 weeks since prior radiotherapy unless disease progression
Surgery:
- Not specified
Other:
- No other concurrent medication that may interfere with study
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
Additional Information:
No publications provided
| Responsible Party: | Henry Friedman, MD, Duke UMC |
| ClinicalTrials.gov Identifier: | NCT00003467 History of Changes |
| Other 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: | October 12, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by Duke University:
|
recurrent adult brain tumor adult brain stem glioma adult mixed glioma |
adult anaplastic astrocytoma adult pilocytic astrocytoma adult oligodendroglioma |
Additional relevant MeSH terms:
|
Glioma Nervous System Neoplasms Central Nervous System Neoplasms Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
Neoplasms by Site Nervous System Diseases Carmustine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013