temozolomide in treating adults with newly diagnosed primary malignant glioblastoma multiforme

Conditions: Brain and Central Nervous System Tumors

Summary: 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.

Eligibility criteria:
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

Keywords: adult glioblastoma adult giant cell glioblastoma adult gliosarcoma