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Safety and Efficacy of Talampanel in Glioblastoma Multiforme

Sponsor
Teva Branded Pharmaceutical Products R&D, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00267592
Collaborator
(none)
72
Enrollment
1
Arm
62
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Talampanel
  • Radiation: Radiation Therapy (RT) 5 days a week +
  • Drug: temozolomide(TMZ) 75mg
  • Drug: adjuvant TMZ 200mg
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
72 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Trial of Talampanel in Conjunction With Radiation Therapy With Concurrent and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme
Study Start Date :
Dec 1, 2005
Actual Primary Completion Date :
Sep 1, 2008
Actual Study Completion Date :
Feb 1, 2011

Arms and Interventions

Arm Intervention/Treatment
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.

Drug: Talampanel
Talampanel administered orally TID beginning the first day and continued until there is talampanel-related toxicity or tumor progression.

Radiation: Radiation Therapy (RT) 5 days a week +

Drug: temozolomide(TMZ) 75mg
temozolomide(TMZ) 75mg 3 times daily (TID) for 6 weeks

Drug: adjuvant TMZ 200mg
adjuvant TMZ 200mg TID for 5 consecutive days each month for a total of 6 months.

Outcome Measures

Primary Outcome Measures

  1. Overall Survival [24 months]

Secondary Outcome Measures

  1. Talampanel-related toxicity [29 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

No locations specified.

Sponsors and Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Teva Branded Pharmaceutical Products R&D, Inc.
ClinicalTrials.gov Identifier:
NCT00267592
Other Study ID Numbers:
  • IXR-207-21-189 / NABTT 0304
  • NCT00082992
First Posted:
Dec 21, 2005
Last Update Posted:
May 19, 2016
Last Verified:
Apr 1, 2016
Additional relevant MeSH terms:
Glioblastoma
Temozolomide

Study Results

No Results Posted as of May 19, 2016