Safety and Efficacy of Talampanel in Glioblastoma Multiforme
This study has been completed.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
First received: December 19, 2005
Last updated: March 19, 2013
Last verified: March 2013
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.
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase II Trial of Talampanel in Conjunction With Radiation Therapy With Concurrent and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme
Primary Outcome Measures:
- Overall Survival [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Talampanel-related toxicity [ Time Frame: 29 months ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2008 (Final data collection date for primary outcome measure)
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.
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- Patients with serious concurrent infection or medical illness.
- Patients receiving concurrent chemotherapeutics or investigational agents.
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No publications provided
||Teva Pharmaceutical Industries
History of Changes
|Other Study ID Numbers:
||IXR-207-21-189 / NABTT 0304
|Study First Received:
||December 19, 2005
||March 19, 2013
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 30, 2015
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action