A Phase II Trial of RAD001 in Patients With Recurrent Glioblastoma Multiforme
This was a multicenter, open label, randomized study of RAD001 dosed daily in patients with
recurrent GBM. The study was conducted with 2 parallel groups of patients. Group 1 was
designed to study the biological effects of RAD001 in patients scheduled to undergo salvage
surgical resection, and Group 2 was to enroll patients who were not scheduled for surgery.
Patients in Group 1 were randomly assigned to one of three pre-surgery treatment groups (0,
5 or 10 mg/day RAD001 for 7 days). All patients in Group 2 were to receive a fixed daily
dose of 10 mg/day oral RAD001.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Surgery Group: Percentage Change From the Baseline in S6 Kinase Levels
In the Surgery Group, the primary efficacy assessment was inhibition of Mammalian target of rapamycin (mTOR) as defined as ≥75% S6 phosphorylation. The occurrence of S6 phosphorylation was determined by phosphor-S6 immunohistochemical staining. Tumor cells from the initial surgical resection and from the salvage resection were used for assessments.
Baseline and Day 7-9 (during salvage surgery)
United States: Food and Drug Administration
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|Seattle Cancer Care Alliance||Seattle, Washington 98109|
|Northwestern University||Chicago, Illinois 60611|
|Dana Farber Cancer Institute||Boston, Massachusetts 02115|
|UCLA||Los Angeles, California 90095|
|University of Cincinnati||Cincinnati, Ohio 45267-0502|
|Duke University - Preston Robert Tisch Brain Tumor Center||Durham, North Carolina 27710|