Safety and Efficacy of Talampanel in Glioblastoma Multiforme - Full Text View

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: TP-38	Phase II

ChemIDplus related topics:

Temozolomide

U.S. FDA Resources

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

Further study details as provided by IVAX Research LLC:

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: TP-38 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: TP-38 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

IVAX Research LLC

More Information

Responsible Party:	Teva Neuroscience ( Rivka Kreitman, Ph.D., Vice President, Innovative Research and Development )
Study ID Numbers:	IXR-207-21-189 / NABTT 0304
First Received:	December 19, 2005
Last Updated:	December 21, 2007
ClinicalTrials.gov Identifier:	NCT00267592
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Neuroectodermal Tumors

Glioblastoma

Glioblastoma multiforme

Astrocytoma

Neoplasms, Germ Cell and Embryonal

Neuroepithelioma

Glioma

Temozolomide

Recurrence

Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Neoplasms, Neuroepithelial

ClinicalTrials.gov processed this record on October 20, 2008

Sponsored by:	IVAX Research LLC
Information provided by:	IVAX Research LLC
ClinicalTrials.gov Identifier:	NCT00267592