A Phase II Trial of RAD001 in Patients With Recurrent Glioblastoma Multiforme
18 Years
N/A
Both
Glioblastoma Multiforme
Trial Information
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.
Inclusion Criteria:
- Age 18 years of age or older
- Histologically confirmed Glioblastoma Multiforme (GBM)
- Radiographic evidence of disease progression
- Patients must have evaluable contrast enhancing tumor
- Availability of paraffin blocks or unstained pathology slides for biomarker studies
- Karnofsky Performance Status of greater than or equal to 60%
Exclusion Criteria:
- Prior treatment with Mammalian target of rapamycin (mTOR) inhibitor
- History of another malignancy within 3 years
- Cardiac pacemaker
- Ferromagnetic metal implants other than those approves as safe for use in Magnetic
resonance imaging (MRI) scanners
- Claustrophobia
- Obesity
- Unstable systemic diseases
- Elevated cholesterol or triglycerides
- Radiation therapy or cytotoxic chemotherapy <=4 weeks prior to study enrollment.
Patient must have recovered from the toxic effects of a prior chemotherapy.
- Patients must be off all enzyme inducing anticonvulsants for at least 2 week before
study enrollment can occur
- Need for increasing dose of steroids. Patients on a stable or tapering dose of
steroids >=7 days were permitted.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Surgery Group: Percentage Change From the Baseline in S6 Kinase Levels
Outcome Description:
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.
Outcome Time Frame:
Baseline and Day 7-9 (during salvage surgery)
Safety Issue:
No
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
CRAD001C2410
NCT ID:
NCT00515086
Start Date:
August 2007
Completion Date:
August 2009
Related Keywords:
- Glioblastoma Multiforme
- Glioblastoma Multiforme, GBM, RAD001, RAD
- Glioblastoma
Name | Location |
|---|---|
| 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 |
