Safety and Efficacy of Talampanel in Glioblastoma Multiforme - Tabular View

Tracking Information
First Received Date ^ICMJE	December 19, 2005
Last Updated Date	March 18, 2009
Start Date ^ICMJE	April 2004
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00267592 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy of Talampanel in Glioblastoma Multiforme
Official Title ^ICMJE	A Phase II Trial of Talampanel in Conjunction With Radiation Therapy With Recurrent and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme
Brief Summary	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.
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.
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE
Condition ^ICMJE	Glioblastoma Multiforme
Intervention ^ICMJE	Drug: Talampanel
Study Arms / Comparison Groups	Experimental: Non-enzyme-inducing anti-epileptic drug: week1 25mg TID, week 2 35mg TID, week 3 until off treatment 50mg TID Experimental: Enzyme-inducing anti-epileptic drug: week 1 35mg TID, week 2 50mg TID, week 3 until off treatment 75mg TID
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	72
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00267592
Responsible Party	Rivka Kreitman, Ph.D., Vice President, Innovative Research and Development, Teva Neuroscience
Study ID Numbers ^ICMJE	IXR-207-21-189 / NABTT 0304
Study Sponsor ^ICMJE	Teva Pharmaceutical Industries
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Teva Pharmaceutical Industries
Verification Date	March 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP