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Safety and Efficacy of Talampanel in Glioblastoma Multiforme

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ClinicalTrials.gov Identifier: NCT00267592
Recruitment Status : Completed
First Posted : December 21, 2005
Last Update Posted : May 19, 2016
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries

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
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  (Clinical Trial)
Actual Enrollment : 72 participants
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 : December 2005
Primary Completion Date : September 2008
Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



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

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


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.

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 Posted: December 21, 2005    Key Record Dates
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