Study of Everolimus (RAD001) in Patients With Recurrent Glioblastoma Multiforme (GBM)

• Status: Terminated
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will define the safety and efficacy of Everolimus (RAD001) administered daily in patients with glioblastoma multiforme (GBM)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Everolimus; Sirolimus

Criteria

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.