Temozolomide + Everolimus in Newly Diagnosed, Recurrent, or Progressive Malignant Glioblastoma Multiforme

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed malignant glioblastoma multiforme, meeting 1 of the following criteria:
• * Newly diagnosed disease AND meets the following criteria:
• * Has undergone prior surgery and radiotherapy with concurrent temozolomide
• * No prior chemotherapy except for concurrent low-dose temozolomide given with radiotherapy
• * Recurrent or progressive disease after front-line therapy AND meets the following criteria:
• * No more than 1 prior chemotherapy regimen in the adjuvant setting
• * More than 4 months since last adjuvant treatment
• * No prior chemotherapy for recurrence
• Bidimensionally measurable disease, defined as ≥ 1 enhancing lesion ≥ 1 cm x 1 cm by CT scan or MRI, within 21 days of study entry (for patients with recurrent/relapsed disease)
• * Patients receiving steroids must be on stable dose for at least 14 days before baseline CT scan or MRI
• Paraffin-embedded sample of primary or metastatic tumor diagnostic specimen must be available
• PATIENT CHARACTERISTICS:
• ECOG performance status 0-2
• Life expectancy ≥ 12 weeks
• Absolute granulocyte count ≥ 1,500/mm³
• Platelet count ≥ 120,000/mm³
• Bilirubin normal
• AST and ALT ≤ 2.5 times upper limit of normal
• Creatinine normal OR creatinine clearance ≥ 60 mL/min
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No upper gastrointestinal condition or other condition that would preclude compliance with oral medication
• No other prior malignancy except for adequately treated nonmelanoma skin cancer, curatively treated in situ cervical cancer, or other solid tumors curatively treated with no evidence of disease for the past 5 years
• No serious illness or underlying medical condition that would preclude study compliance, including any of the following:
• * Significant neurologic or psychiatric disorder that would preclude obtaining informed consent
• * Active, ongoing infection
• No known hypersensitivity to everolimus or temozolomide or their components
• PRIOR CONCURRENT THERAPY:
• See Disease Characteristics
• At least 2 weeks since prior surgery and recovered
• At least 4 weeks since prior radiotherapy
• Concurrent enzyme-inducing antiepileptic drugs allowed
• No concurrent inhibitors of cytochrome 3A4 (e.g., ketoconazole and similar antifungals, erythromycin, or diltiazem)
• No other concurrent experimental drugs, anticancer treatment, or investigational therapy
• No concurrent grapefruit juice