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

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