A Phase II Trial of Temozolomide and BCNU for Anaplastic Gliomas

Fecha de inicio: 25 de marzo de 1998

DISEASE CHARACTERISTICS: Histologically confirmed malignant glioma - Recurrent glioblastoma - Anaplastic astrocytoma - Mixed anaplastic glioma For recurrent glioblastoma: Required documented progression must include an increase in tumor size of at least 25% or appearance of new lesion For anaplastic astrocytoma or mixed anaplastic glioma: Must have measurable, contrast enhancing disease on postoperative CT or MRI scan No postoperative radiation or chemotherapy If patients have received prior brachytherapy or stereotactic radiosurgery, they must have confirmation of true progressive disease rather than radiation necrosis by PET scanning or biopsy PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Absolute neutrophil count at least 1,800/mm3 Platelet count at least 125,000/mm3 Hemoglobin at least 9 g/dL (transfusion allowed) Hepatic: Bilirubin less than 1.5 mg/dL SGOT less than 2.0 times upper limit of normal Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than 70 mL/min Cardiovascular: No uncontrolled arrhythmias or conduction defects No unstable or newly diagnosed angina pectoris No New York Heart Association class II-IV heart disease No congestive heart failure No major problems with edema (e.g., severe Cushing's syndrome, residual leg swelling from deep-vein thrombosis) No recent coronary artery disease No poorly controlled hypertension (diastolic greater than 110 mmHg and systolic greater than 180 mmHg) Pulmonary: DLCO greater than 80% of expected value Other: HIV negative No major psychiatric illness No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been free of disease for 5 years Not pregnant or nursing Adequate contraception required of all fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy: No prior nitrosourea or temozolomide No more than 1 prior chemotherapy regimen allowed for patients with glioblastoma At least 6 weeks since mitomycin or procarbazine and recovered At least 4 weeks since other prior chemotherapy and recovered No other concurrent chemotherapy Endocrine therapy: If receiving steroids, must be on a stable steroid dose for at least 72 hours prior to study No other concurrent endocrine therapy Radiotherapy: At least 6 weeks since radiotherapy No greater than 10-20% of marrow irradiated in prior radiotherapy No other concurrent radiotherapy Surgery: Surgery allowed