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

Stopped early · Phase 2

Conditions studied: Glioblastoma Multiforme

In brief

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

Key facts

Study ID

NCT00515086

Run by

Novartis Pharmaceuticals

People needed

41

Starts

2007-08-01

Expected to finish

2009-08-01

Last updated by the study team

2011-09-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%

You may not qualify if…

• 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.

Where it is running

• UCLA — Los Angeles, California, United States
• Northwestern University — Chicago, Illinois, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Duke University - Preston Robert Tisch Brain Tumor Center — Durham, North Carolina, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Seattle Cancer Care Alliance — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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