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

NCT ID: NCT00515086

Last Updated: 2011-09-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2009-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Glioblastoma Multiforme

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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No Surgery (Everolimus 10 mg)

Participants with recurrent Glioblastoma Multiforme (GBM) not scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus (RAD001) until evidence of disease progression or toxicity.

Group Type EXPERIMENTAL

Everolimus

Intervention Type DRUG

Tablets taken once a day with a full glass of water.

Everolimus 10 mg + Surgery

Participants scheduled to undergo salvage surgical resection received a daily oral dose of 10 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.

Group Type EXPERIMENTAL

Everolimus

Intervention Type DRUG

Tablets taken once a day with a full glass of water.

Surgery

Intervention Type PROCEDURE

Salvage surgical resection

Everolimus 5 mg + Surgery

Participants scheduled to undergo salvage surgical resection received a daily oral dose of 5 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.

Group Type EXPERIMENTAL

Everolimus

Intervention Type DRUG

Tablets taken once a day with a full glass of water.

Surgery

Intervention Type PROCEDURE

Salvage surgical resection

Everolimus 0 mg + Surgery

Participants scheduled to undergo salvage surgical resection received no treatment with Everolimus prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.

Group Type ACTIVE_COMPARATOR

Everolimus

Intervention Type DRUG

Tablets taken once a day with a full glass of water.

Surgery

Intervention Type PROCEDURE

Salvage surgical resection

Interventions

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Everolimus

Tablets taken once a day with a full glass of water.

Intervention Type DRUG

Surgery

Salvage surgical resection

Intervention Type PROCEDURE

Other Intervention Names

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RAD001

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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UCLA

Los Angeles, California, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Duke University - Preston Robert Tisch Brain Tumor Center

Durham, North Carolina, United States

Site Status

University of Cincinnati

Cincinnati, Ohio, United States

Site Status

Seattle Cancer Care Alliance

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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CRAD001C2410

Identifier Type: -

Identifier Source: org_study_id