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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00515086
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Novartis Pharmaceuticals
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Novartis Pharmaceuticals
Principal Investigator Affiliation Novartis Pharmaceuticals
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Terminated
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma Multiforme
Additional Details

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.

Arms & Interventions

Arms

Experimental: 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.

Experimental: 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.

Experimental: 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.

Active Comparator: 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.

Interventions

Drug: - Everolimus

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

Procedure: - Surgery

Salvage surgical resection

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

UCLA, Los Angeles, California

Status

Address

UCLA

Los Angeles, California, 90095

Northwestern University, Chicago, Illinois

Status

Address

Northwestern University

Chicago, Illinois, 60611

Massachusetts General Hospital, Boston, Massachusetts

Status

Address

Massachusetts General Hospital

Boston, Massachusetts, 02114

Beth Israel Deaconess Medical Center, Boston, Massachusetts

Status

Address

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115

Dana Farber Cancer Institute, Boston, Massachusetts

Status

Address

Dana Farber Cancer Institute

Boston, Massachusetts, 02115

Durham, North Carolina

Status

Address

Duke University - Preston Robert Tisch Brain Tumor Center

Durham, North Carolina, 27710

University of Cincinnati, Cincinnati, Ohio

Status

Address

University of Cincinnati

Cincinnati, Ohio, 45219

Seattle Cancer Care Alliance, Seattle, Washington

Status

Address

Seattle Cancer Care Alliance

Seattle, Washington, 98109

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