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A Phase II Trial of RAD001 in Patients With Recurrent Glioblastoma Multiforme


Phase 2
18 Years
N/A
Not Enrolling
Both
Glioblastoma Multiforme

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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 CenterBoston, Massachusetts  02215
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Seattle Cancer Care AllianceSeattle, Washington  98109
Northwestern UniversityChicago, Illinois  60611
Dana Farber Cancer InstituteBoston, Massachusetts  02115
UCLALos Angeles, California  90095
University of CincinnatiCincinnati, Ohio  45267-0502
Duke University - Preston Robert Tisch Brain Tumor CenterDurham, North Carolina  27710