Study of Everolimus in Patients With Recurrent Glioblastoma Multiforme - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00515086

Purpose

This study will define the safety and efficacy of RAD001 administered daily in patients with glioblastome multiforme

Condition	Intervention	Phase
Glioblastoma Multiforme	Drug: everolimus (RAD001) Drug: everolimus (RAD001)	Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Everolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Pilot Multicenter Phase I/II Trial of RAD001 in Patients With Recurrent Glioblastoma Multiforme

Further study details as provided by Novartis:

Primary Outcome Measures:

• Determine the effect of everolimus on S6 kinase inhibition • Determine the clinical efficacy based on the evaluation of the objective tumor response rate •

Secondary Outcome Measures:

Track the amount of everolimus in blood and tumor • Determine the duration of time to tumor progression • Determine the type, number and severity of side effects • Determine the effect of everolimus on PTEN and EGFR • Determine the progre

Study Start Date:

October 2006

Arms	Assigned Interventions
ARM 1 everolimus Subjects with recurrent GBM scheduled to undergo salvage surgery. Subjects will receive RAD001 for approximatley 7 days before surgery. After recovery they will receive a fixed daily dose of RAD001	Drug: everolimus (RAD001)
Arm 2 everolimus Subjects with recurrent GBM not undergoing a planned salvage surgical resection will receive a fixed daily dose of RAD001	Drug: everolimus (RAD001)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 18 years of age or older
Histologically confirmed GBM
Radiographic evidence of disease progression
Patients should be on a non-increasing dose of steroids for at least 7 days prior to obtaining the baseline Gd-MRI of the brain
Patients must have evaluable contrast enhancing tumor
Patients must be off all enzyme inducing anticonvulsants for at least 2 week before study enrollment can occur
Availability of paraffin blocks or unstained pathology slides for biomarker studies
Karnofsky Performance Status of greater than or equal to 60% Recovery from the toxic effects of a prior chemo therapy and 4 weeks recovery from an investigational agent

Exclusion Criteria:

Prior treatment with mTOR inhibitor
History of another malignancy within 3 years
Cardiac pacemaker
Ferromagnetic metal implants other than those approves as safe for use in MRI scanners
Clautophobia
Obesity
Unstable systemic diseases
Elevaetd cholesterol or triglycerides

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00515086

Locations

United States, California
UCLA	Recruiting
Los Angeles, California, United States, 90095
Contact: Emese Filka 310-794-3521 efilka@mednet.ucla.edu
Principal Investigator: Timothy Cloughesy, MD
United States, Georgia
Emory University - Winship Cancer Center	Withdrawn
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern University	Recruiting
Chicago, Illinois, United States, 60611
Contact: Lilia Gallot 312-503-4724 l-gallot@northwestern.edu
Principal Investigator: Jeffrey Raizer, MD
United States, Massachusetts
Dana Farber Cancer Institute	Recruiting
Boston, Massachusetts, United States, 02115
Contact: Jenny Zimmerman 617-632-6684
Contact: Phuong Phan 617-582-7674 phuong_phan@dfci.harvard.edu
Principal Investigator: Jan Drappatz, MD
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Colin Doyle 617-724-5059 cldoyle@partners.org
Principal Investigator: Jan Drappatz, M.D.
Beth Israel Deaconess Medical Center	Recruiting
Boston, Massachusetts, United States, 02115
Contact: Lorretta Barron 617-667-3298 lbarron@bidmc.harvard.edu
Principal Investigator: Jan Drappatz, M.D.
United States, North Carolina
Duke University - Preston Robert Tisch Brain Tumor Center	Recruiting
Durham, North Carolina, United States, 27710
Contact: Sarah Woodring 919-681-1691 sarah.woodring@duke.edu
Contact: Peggy Lynons, BSN 919-668-2447 lyons02@mc.dike.edu
Principal Investigator: Annick DesJardins, M.D.
United States, Ohio
University of Cincinnati	Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Amy Stevens 513-584-6178 amy.stevens@healthall.com
Principal Investigator: Margie Lewis, M.D.
United States, Washington
Seattle Cancer Care Alliance	Not yet recruiting
Seattle, Washington, United States, 98109
Contact: Lisa Mandell, R.N. 206-616-8967 mandell5@u.washington.edu
Principal Investigator: Marc Chamberlain, M.D.

Sponsors and Collaborators

Novartis

More Information

Study ID Numbers:	CRAD001C2410
Study First Received:	August 10, 2007
Last Updated:	July 10, 2008
ClinicalTrials.gov Identifier:	NCT00515086
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Glioblastoma Multiforme, GBM, RAD001, RAD

Study placed in the following topic categories:

Everolimus
Neuroectodermal Tumors
Glioblastoma
Glioblastoma multiforme
Astrocytoma

Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Glioma
Recurrence
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Physiological Effects of Drugs

Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009