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Safety and Efficacy of Talampanel in Glioblastoma Multiforme

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00267592
First received: December 19, 2005
Last updated: March 19, 2013
Last verified: March 2013

December 19, 2005
March 19, 2013
December 2005
September 2008   (final data collection date for primary outcome measure)
Overall Survival [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00267592 on ClinicalTrials.gov Archive Site
Talampanel-related toxicity [ Time Frame: 29 months ] [ Designated as safety issue: Yes ]
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Safety and Efficacy of Talampanel in Glioblastoma Multiforme
A Phase II Trial of Talampanel in Conjunction With Radiation Therapy With Concurrent and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme

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.

Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Glioblastoma Multiforme
Drug: Talampanel
Radiation Therapy (RT) 5 days a week + temozolomide(TMZ) 75mg 3 times daily (TID) for 6 weeks. One month later, adjuvant TMZ 200mg TID for 5 consecutive days each month for a total of 6 months. Talampanel was administered orally TID beginning the first day of RT + TMZ and continued until there was talampanel-related toxicity or tumor progression.
Experimental: enzyme-inducing antiseizure drug
A single-arm study with all subjects assigned to one treatment (radiation + temozolomide + talampanel) but subjects receiving concomitant anti-seizure drugs which could increase study drug elimination had a slightly modified dose/schedule of study drug. The primary endpoint is analyzed as a single group.
Intervention: Drug: Talampanel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
February 2011
September 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00267592
IXR-207-21-189 / NABTT 0304
Not Provided
Teva Pharmaceutical Industries
Teva Pharmaceutical Industries
Not Provided
Not Provided
Teva Pharmaceutical Industries
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP