Talampanel in Treating Patients With Recurrent High-Grade Glioma

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Brain and Central Nervous System Tumors

Intervention / Treatment
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* Drug: talampanel


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed high-grade glioma, including any of the following: Glioblastoma multiforme Anaplastic astrocytoma Anaplastic oligodendroglioma Anaplastic mixed oligoastrocytoma Malignant astrocytoma not otherwise specified Patients with clinical and radiographic diagnosis of brain stem glioma are also eligible Evidence of tumor progression by MRI or CT scan Scan must be performed while patient is on a stable steroid dose for at least 5 days Must have failed prior radiotherapy Residual disease after prior resection of recurrent or progressive tumor is allowed PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 60-100% Life expectancy More than 8 weeks Hematopoietic Absolute neutrophil count greater than 1,500/mm^3 Platelet count at least 100,000/mm^3 (transfusion independent) Hemoglobin at least 10 g/dL (transfusion allowed) Hepatic Bilirubin less than 2 times upper limit of normal (ULN) SGOT less than 2 times ULN No significant active hepatic disease Renal Creatinine less than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min No significant active renal disease Cardiac No significant active cardiac disease Other Not pregnant or nursing Negative pregnancy test Fertile patients must use 2 effective methods of contraception during and for 2 months after study participation Able to swallow whole capsules No active infection requiring IV antibiotics No significant active psychiatric disease that would preclude use of the study drug No other significant uncontrolled medical illness that would preclude study participation No other active life-threatening malignancy PRIOR CONCURRENT THERAPY: Biologic therapy At least 1 week since prior interferon or thalidomide No concurrent anticancer immunotherapy Chemotherapy At least 2 weeks since prior vincristine At least 3 weeks since prior procarbazine At least 6 weeks since prior nitrosoureas No other concurrent anticancer chemotherapy Endocrine therapy See Disease Characteristics At least 1 week since prior tamoxifen Concurrent steroids for the control of increased intracranial pressure allowed Radiotherapy See Disease Characteristics At least 4 weeks since prior radiotherapy No concurrent anticancer radiotherapy Surgery See Disease Characteristics Prior recent resection of recurrent or progressive disease allowed Other Recovered from all prior therapy At least 1 week since prior noncytotoxic agents (e.g., isotretinoin), except for radiosensitizers At least 4 weeks since prior investigational agents At least 4 weeks since prior cytotoxic therapy No other concurrent investigational agents

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: talampanel|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression at 6 months |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent adult brain tumor, adult anaplastic astrocytoma, adult glioblastoma, adult anaplastic oligodendroglioma, adult mixed glioma, adult giant cell glioblastoma, adult gliosarcoma, adult brain stem glioma