sarcnu in treating patients with recurrent malignant glioma

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 sarcnu in treating patients who have recurrent malignant glioma.

objectives: * determine the efficacy of sarcnu, in terms of objective response and duration of response, in patients with recurrent malignant gliomas. * determine the qualitative and quantitative toxic effects of this drug in these patients. * determine the time to progression and survival of patients treated with this drug. outline: this is a multicenter study. patients receive oral sarcnu on days 1, 5, and 9. treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. patients are followed at 4 weeks and then every 3 months thereafter. projected accrual: a total of 15-30 patients will be accrued for this study within 12-18 months.

Eligibility criteria:
disease characteristics: * histologically confirmed malignant glioma * anaplastic astrocytoma (aa) or * glioblastoma multiforme (gbm) * recurrent or progressive disease by contrast-enhanced ct scan or mri after primary surgery and radiotherapy * at least 1 bidimensionally measurable lesion * at least 1 cm by 1 cm on contrast-enhanced ct scan or mri patient characteristics: age: * 18 and over performance status: * ecog 0-2 life expectancy: * at least 12 weeks hematopoietic: * absolute granulocyte count at least 1,500/mm3 * platelet count at least 120,000/mm3 hepatic: * bilirubin normal * ast and alt no greater than 2.5 times upper limit of normal renal: * creatinine normal or * creatinine clearance at least 60 ml/min cardiovascular: * no symptomatic congestive heart failure * no unstable angina pectoris * no cardiac arrhythmia pulmonary: * dlco at least 70% of predicted * fvc at least 70% of predicted other: * no other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix * no ongoing or active uncontrolled infection * no other serious illness or medical condition that would preclude study * no history of significant neurologic or psychiatric disorder that would preclude study * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception during and for at least 3 months after study prior concurrent therapy: biologic therapy: * at least 6 weeks since prior immunotherapy * no concurrent immunotherapy chemotherapy: * at least 6 weeks since prior chemotherapy * no more than 1 prior adjuvant chemotherapy regimen for aa * no prior chemotherapy for recurrent disease * no other concurrent chemotherapy endocrine therapy: * patients must be on a stable dose of steroids for at least 2 weeks prior to study radiotherapy: * see disease characteristics * at least 4 weeks since prior radiotherapy * no prior radiotherapy for recurrent disease * no concurrent radiotherapy surgery: * see disease characteristics * prior surgery for recurrent disease (e.g., stereotactic biopsy or partial resection) allowed * at least 4 weeks since prior surgery (except for biopsy) other: * at least 6 weeks since prior investigational agents * no other concurrent investigational agents * no other concurrent anticancer treatment

Keywords: recurrent adult brain tumor adult glioblastoma adult anaplastic astrocytoma adult giant cell glioblastoma adult gliosarcoma