Safety and Efficacy of Talampanel in Glioblastoma Multiforme

This study is ongoing, but not recruiting participants.

First Received: December 19, 2005 Last Updated: March 18, 2009 History of Changes

Sponsor:	Teva Pharmaceutical Industries
Information provided by:	Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:	NCT00267592

Purpose

The purpose of this study is to estimate overall survival for adult patients with newly diagnosed glioblastoma multiforme treated with talampanel during radiation therapy with concurrent and adjuvant temozolomide. This study will also determine the toxicity and toxicity rate of talampanel for this therapeutic regimen.

Condition	Intervention	Phase
Glioblastoma Multiforme	Drug: Talampanel	Phase II

Study Type:	Interventional
Official Title:	A Phase II Trial of Talampanel in Conjunction With Radiation Therapy With Recurrent and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme

Resource links provided by NLM:

Drug Information available for: GYKI 53773

U.S. FDA Resources

Further study details as provided by Teva Pharmaceutical Industries:

Enrollment:	72
Study Start Date:	April 2004

Arms	Assigned Interventions
1: Experimental Non-enzyme-inducing anti-epileptic drug: week1 25mg TID, week 2 35mg TID, week 3 until off treatment 50mg TID	Drug: Talampanel 25mg, 35mg, 50mg, 75mg, variations of 5 days a week and daily
2: Experimental Enzyme-inducing anti-epileptic drug: week 1 35mg TID, week 2 50mg TID, week 3 until off treatment 75mg TID	Drug: Talampanel 25mg, 35mg, 50mg, 75mg, variations of 5 days a week and daily

Detailed Description:

To estimate the overall survival for adult patients with newly diagnosed glioblastoma multiforme treated with Talampanel administered during radiation therapy with concurrent and adjuvant Temozolomide, as well as to determine the toxicity and estimate the toxicity rate of the drug in such a treatment setting.

Eligibility

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

Criteria

Inclusion Criteria:

Patients must be 18 years of age
Patients must have histologically confirmed supratentorial Grade IV astrocytoma (glioblastoma multiforme)
Patients must not have prior radiation therapy, chemotherapy (including Gliadel wafer), immunotherapy or therapy with a biologic agent, or hormonal therapy. Glucocorticoid therapy is allowed.
Patients must have recovered from the immediate post-operative period and be maintained on a stable corticosteroid regimen (on increase for 5 days) prior to the start of treatment.
Patients must have a Karnofsky performance of at least 60% or more.

Exclusion Criteria:

Patients with serious concurrent infection or medical illness.
Patients receiving concurrent chemotherapeutics or investigational agents.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00267592

Locations

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
The Cleveland Clinical Foundation
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
University of Pennsylvania Department of Neurology
Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

Teva Pharmaceutical Industries

More Information

No publications provided

Responsible Party:	Teva Neuroscience ( Rivka Kreitman, Ph.D., Vice President, Innovative Research and Development )
Study ID Numbers:	IXR-207-21-189 / NABTT 0304
Study First Received:	December 19, 2005
Last Updated:	March 18, 2009
ClinicalTrials.gov Identifier:	NCT00267592 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neuroectodermal Tumors
Glioblastoma
Neoplasms
Neoplasms by Histologic Type
Astrocytoma

Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Glioma
Neoplasms, Neuroepithelial
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009