Safety and Efficacy of Talampanel in Glioblastoma Multiforme

April 20, 2016 updated by: Teva Branded Pharmaceutical Products R&D, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Talampanel-related toxicity
Time Frame: 29 months
29 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

December 19, 2005

First Submitted That Met QC Criteria

December 20, 2005

First Posted (Estimate)

December 21, 2005

Study Record Updates

Last Update Posted (Estimate)

May 19, 2016

Last Update Submitted That Met QC Criteria

April 20, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IXR-207-21-189 / NABTT 0304

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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