Expired Study
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Bethesda, Maryland 20892


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00064363


Primary Contact:

Study Chair
Howard A. Fine, MD
NCI - Neuro-Oncology Branch


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 17, 2017

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