High-Dose Methotrexate and Leucovorin in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed glioblastoma multiforme (GBM)
• * Supratentorial grade IV disease
• Measurable and contrast-enhancing disease ≥ 1 cm by CT scan or MRI
• No radiographic evidence of ascites or pleural effusion
• PATIENT CHARACTERISTICS:
• Age
• 18 and over
• Performance status
• ECOG 0-2
• Life expectancy
• Not specified
• Hematopoietic
• Absolute neutrophil count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Hepatic
• SGOT ≤ 4.0 times upper limit of normal
• Bilirubin ≤ 2.0 mg/dL
• Renal
• Creatinine ≤ 2.0 mg/dL
• Creatinine clearance ≥ 50 mL/min
• Cardiovascular
• No uncontrolled hypertension
• No unstable angina
• No symptomatic congestive heart failure
• No uncontrolled cardiac arrhythmia
• No myocardial infarction within the past 6 months
• Other
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Able to achieve hydration
• No diabetes insipidus
• No known hypersensitivity to methotrexate or leucovorin calcium
• No concurrent serious infection or medical illness that would preclude study participation
• No other malignancy within the past 2 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
• PRIOR CONCURRENT THERAPY:
• Biologic therapy
• No prior immunotherapy for GBM
• No prior administration of any of the following biologic agents for GBM:
• * Immunotoxins
• * Immunoconjugates
• * Antisense therapy
• * Peptide receptor antagonists
• * Interferons
• * Interleukins
• * Tumor-infiltrating lymphocytes
• * Lymphokine-activated killer cells
• * Gene therapy
• No concurrent prophylactic growth factors (e.g., filgrastim \[G-CSF\] or sargramostim \[GM-CSF\])
• Chemotherapy
• No prior chemotherapy for GBM
• No other concurrent chemotherapy
• Endocrine therapy
• Prior glucocorticoid therapy allowed
• No prior hormonal therapy for GBM
• Patients must be maintained on a stable corticosteroid regimen for at least 1 week
• Radiotherapy
• No prior cranial irradiation
• No prior radiotherapy for GBM
• Surgery
• Recovered from prior surgery
• Other
• At least 1 week since prior treatment with any of the following:
• * Salicylates
• * Non-steroidal anti-inflammatory drugs
• * Sulfonamide medications
• * Vitamin C
• No other concurrent investigational agents