Phase I/II Trial of Concurrent RAD001 (Everolimus) With Temozolomide/Radiation Followed by Adjuvant RAD001/Temozolomide in Newly Diagnosed Glioblastoma
Principal Investigator
Prakash Chinnaiyan, MD
Status
Terminated
Date Opened To Accrual
October 28 2010
Date Closed to Accrual
September 12 2013
Date of Study Termination
May 20 2022
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
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.