Brain and Central Nervous System Tumors Clinical Trial
Official title:
A Phase II Trial Of Talampanel In Patients With Recurrent High-Grade Gliomas
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.
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.
;
Masking: Open Label, Primary Purpose: Treatment
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