Temozolomide in Treating Adults With Newly Diagnosed Primary Malignant Glioblastoma Multiforme

Duke University50 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 temozolomide in treating adults with newly diagnosed primary malignant glioblastoma multiforme.

OBJECTIVES: * Determine the antitumor activity of temozolomide in adults with newly diagnosed glioblastoma multiforme. * Define the relationship between tumor O6-alkylguanine-DNA alkyltransferase activity and tumor response in these patients. * Define the relationship between tumor DNA mismatch repair activity and tumor response to temozolomide. OUTLINE: Patients receive temozolomide orally once daily on days 1-5. Treatment courses are repeated every 28 days. In the absence of disease progression and toxicity, patients receive up to 4 courses of treatment prior to radiation therapy. After radiation therapy, patients demonstrating partial or complete response may receive an additional 12 courses of treatment. Patients are followed every 8-12 weeks for 2 years. PROJECTED ACCRUAL: This study will accrue 50 patients.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Brain and Central Nervous System Tumors

Interventions

temozolomideDRUG

radiation therapyRADIATION

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Histologically proven, newly diagnosed, supratentorial malignant glioblastoma multiforme not requiring immediate radiation therapy * At least 1 bidimensionally measurable lesion PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 70-100% Life expectancy: * Greater than 12 weeks Hematopoietic: * Absolute neutrophil count at least 1500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic: * Bilirubin less than 1.5 times upper limit of normal (ULN) * SGOT and SGPT less than 2.5 times ULN * Alkaline phosphatase less than 2 times ULN Renal: * BUN less than 1.5 times ULN * Creatinine less than 1.5 times ULN Other: * Must be neurologically stable * No systemic disease * No acute infection requiring intravenous antibiotics * No frequent vomiting * No other medical condition that would interfere with oral medication intake such as partial bowel obstruction * No prior or concurrent malignancies except: * Surgically cured carcinoma in situ of the cervix * Basal or squamous cell carcinoma of the skin * HIV negative * No AIDS-related illness * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior biologic therapy * No concurrent biologic therapy (growth factors or erythropoietin) Chemotherapy: * No prior chemotherapy * No other concurrent chemotherapy Endocrine therapy: * Concurrent steroid allowed (must be on stable dose for at least 1 week prior to study) Radiotherapy: * No prior radiation therapy * No prior interstitial brachytherapy * No prior radiosurgery to the brain * Not requiring immediate radiation therapy * No concurrent radiotherapy Surgery: * Recovered from any effects of prior surgery * At least 2 weeks since prior surgical resection Other: * No other concurrent investigational drugs

Locations (1)

Duke Comprehensive Cancer Center

Durham, North Carolina, United States

Data from ClinicalTrials.gov

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