Carmustine in Treating Adults With Recurrent Supratentorial Low-Grade Glioma

Duke University68 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Brain and Central Nervous System Tumors

Interventions

carmustineDRUG

polifeprosan 20 with carmustine implantDRUG

surgical procedurePROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Duke Comprehensive Cancer Center

Durham, North Carolina, United States

Data from ClinicalTrials.gov

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