NCT00064363

Talampanel in Treating Patients With Recurrent High-Grade Glioma

A Phase II Trial Of Talampanel In Patients With Recurrent High-Grade Gliomas

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: National Institutes of Health Clinical Center (CC) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy such as talampanel use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well talampanel works in treating patients with recurrent, progressive high-grade glioma.

Detailed description

OBJECTIVES: * Determine the efficacy of talampanel, in terms of 6-month progression-free survival, in patients with recurrent high-grade gliomas. * Determine, preliminarily, the toxic effects of this drug in these patients. * Determine, preliminarily, the quality of life of patients treated with this drug. * Determine the pharmacokinetics of this drug in patients who are and who are not receiving enzyme-inducing antiepileptic drugs. OUTLINE: Patients are stratified according to type of glioma (anaplastic astrocytoma vs glioblastoma multiforme). Patients in each stratum are assigned to 1 of 3 treatment groups according to concurrent enzyme-inducing antiepileptic drug use (yes, no, or valproic acid). Patients in each group receive different doses of oral talampanel 3 times daily on days 1-42. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, every 3 weeks during the first course, every 6 weeks before all subsequent courses, and then within 2 weeks of study completion. Patients are followed within 2 weeks. PROJECTED ACCRUAL: A total of 91 patients (50 with anaplastic astrocytoma and 41 with glioblastoma multiforme) will be accrued for this study within 1 year.

Conditions

• Brain and Central Nervous System Tumors

Interventions

Type	Name	Description
DRUG	talampanel

Timeline

• Start date: 2003-06-01
• Completion: 2007-02-01
• First posted: 2003-07-09
• Last updated: 2012-03-08

Locations

1 site across 1 country: United States