RTOG-0913

Phase I/II Trial of Concurrent RAD001 (Everolimus) with Temozolomide/Radiation Followed by Adjuvant RAD001/Temozolomide in Newly Diagnosed Glioblastoma

Principal Investigator

Prakash Chinnaiyan

Status

Disease Site

Brain [BN] Other

Phase

I/II

Developmental Therapeutics

No

Primary Objective

Phase I: To define the maximum tolerated dose of RAD001 (up to established dose of 10 mg/day) when combined with concurrent radiation and temozolomide in newly diagnosed GBM.

Phase II: 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. 

Data Collection Notice:

Data for this trial is being collected via the NRG/RTOG Data Center.

Patient Population

Histopathologically proven diagnosis of glioblastoma (WHO Grade IV) confirmed by central pathology review prior to Step 2 registration. Tumor tissue available for correlative studies (PHASE II ONLY)

Target Accrual

246