Radiation Therapy and Temsirolimus or Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma

DISEASE CHARACTERISTICS:

• Histologically confirmed (by open brain biopsy or from a neurosurgical resection of the tumor) supratentorial glioblastoma multiforme (GBM)
• WHO grade IV disease
• Newly diagnosed disease
• Must provide demonstration of an unmethylated MGMT-promoter
• At least 2 weeks and no more than 6 weeks since surgery or open biopsy
• Tumor tissue specimens (paraffin-embedded and/or frozen) from the GBM surgery or open biopsy must be available for central pathology review, MGMT status determination, and exploratory analysis of PI3-K/Akt/mTOR targets (P70S6K)

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2
• Life expectancy ≥ 12 weeks
• WBC ≥ 3.0 x 10^9/L
• Absolute neutrophil count ≥ 1.5 x10^9/L
• Platelet count ≥ 75.0 x 10^9/L
• Hemoglobin ≥ 10.0 g/dL
• Bilirubin ≤ 1.5 times the upper limit of normal (ULN)
• Alkaline phosphatase ≤ 2.5 x ULN
• AST and/or ALT ≤ 2.5 x ULN
• Serum creatinine < 1.5 x ULN
• PT and PTT normal
• Negative pregnancy test
• Not pregnant or nursing
• Fertile patients must use highly effective contraception
• No ischemic heart disease in the past 6 months
• 12-lead ECG normal
• No history of stroke
• No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
• No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or nonmelanoma skin cancer (with no subsequent evidence of recurrence)
• No serious concurrent systemic disorder including any of the following that, in the opinion of the investigator, would compromise the patient's ability to adhere to the protocol:
• Active infection
• HIV infection
• Cardiac disease
• QTc prolongation > 450/470 msec (males/females)
• No patients with a congenital long-QT-syndrome in their own or family medical history, unless eligible at the investigator's discretion
• No known hypersensitivity to the study treatment
• No known hypersensitivity to antihistamines or other medical reason that prohibits the intake of antihistamines
• No current alcohol dependence or drug abuse
• No legal incapacity or limited legal capacity
• Able to undergo a gadolinium-enhanced MRI of the brain

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• At least 4 weeks since prior and no concurrent investigational agent
• No prior stereotactic biopsy
• At least 30 days since prior drug therapy that has not received regulatory approval for any indication
• No chemotherapy within the past 5 years
• No prior chemotherapy for a brain tumor
• No prior radiotherapy to the head
• No other concurrent anticancer therapy
• No concurrent anticoagulation therapy except low-dose prophylactic low molecular weight heparin
• Concurrent steroid therapy allowed provided patient is on a stable or decreasing dose for ≥ 1 week
• At least 14 days since prior and no concurrent enzyme-inducing anticonvulsants (e.g., carbamazepine, phenobarbital, and phenytoin)
• No concurrent strong inducers or inhibitors of CYP3A4
• No concurrent planned surgery for other diseases (e.g., dental extraction)
• No placement of Gliadel® wafer during prior surgery