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Phase I/II Trial of Concurrent RAD001 (Everolimus) With Temozolomide/Radiation Followed by Adjuvant RAD001/Temozolomide in Newly Diagnosed Glioblastoma
Phase I
Primary Objective
To define the maximum tolerated dose of RAD001 (up to established dose of 10mg/day) when combined with concurrent radiation and temozolomide in newly diagnosed GBM.
Secondary Objective
To characterize the safety profile of RAD001 in combination with radiation and temozolomide.
Phase II
Primary Objective
To determine the efficacy of RAD001 in combination with radiation and temozolomide followed by RAD001 in combination with temozolomide in patients with newly diagnosed GBM as measured by progression-free survival.
Secondary Objectives
To determine overall survival in newly diagnosed GBM treated with the study regimen.
To further evaluate the safety profile of RAD001 in combination with radiation and temozolomide in this patient population.
To determine if activation of the Akt/mTOR axis predicts response to RAD001 therapy.
To determine if there is an association between tumor MGMT gene methylation status and response to RAD001
Phase I
Primary Objective
To define the maximum tolerated dose of RAD001 (up to established dose of 10mg/day) when combined with concurrent radiation and temozolomide in newly diagnosed GBM.
Secondary Objective
To characterize the safety profile of RAD001 in combination with radiation and temozolomide.
Phase II
Primary Objective
To determine the efficacy of RAD001 in combination with radiation and temozolomide followed by RAD001 in combination with temozolomide in patients with newly diagnosed GBM as measured by progression-free survival.
Secondary Objectives
To determine overall survival in newly diagnosed GBM treated with the study regimen.
To further evaluate the safety profile of RAD001 in combination with radiation and temozolomide in this patient population.
To determine if activation of the Akt/mTOR axis predicts response to RAD001 therapy.
To determine if there is an association between tumor MGMT gene methylation status and response to RAD001
Recruitment Status
Past Studies