Everolimus, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

OBJECTIVES: Primary * To define the maximum tolerated dose of everolimus (up to an established dose of 10 mg/day) when combined with concurrent radiotherapy and temozolomide in patients with newly diagnosed glioblastoma multiforme. (Phase I) * To determine the efficacy of everolimus in combination with radiotherapy and temozolomide followed by adjuvant everolimus in combination with temozolomide, as measured by progression-free survival, in these patients. (Phase II) Secondary * To characterize the safety profile of everolimus in combination with radiotherapy and temozolomide in these patients. (Phase I) * To determine the overall survival of these patients. (Phase II) * To further evaluate the safety profile of everolimus in combination with radiotherapy and temozolomide in these patients. (Phase II) * To determine if activation of the Akt/mTOR axis predicts response to everolimus. (Phase II) * To determine if there is an association between tumor MGMT gene methylation status and response to everolimus. (Phase II) OUTLINE: This is a multicenter, phase I, dose-escalation study of everolimus followed by a phase II, randomized study. After completion of study treatment, patients are followed up every 3 months for 1 year, every 4 months for 1 year, and then every 6 months thereafter.