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Safety and Efficacy of Talampanel in Glioblastoma Multiforme

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00267592
First Posted: December 21, 2005
Last Update Posted: May 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
  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: Talampanel Radiation: Radiation Therapy (RT) 5 days a week + Drug: temozolomide(TMZ) 75mg Drug: adjuvant TMZ 200mg Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 24 months ]

Secondary Outcome Measures:
  • Talampanel-related toxicity [ Time Frame: 29 months ]

Enrollment: 72
Study Start Date: December 2005
Study Completion Date: February 2011
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
No Contacts or Locations Provided
  More Information

Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT00267592     History of Changes
Obsolete Identifiers: NCT00082992
Other Study ID Numbers: IXR-207-21-189 / NABTT 0304
First Submitted: December 19, 2005
First Posted: December 21, 2005
Last Update Posted: May 19, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents