Clinical Trial Finder

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

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.#46; 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.