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Talampanel in Treating Patients With Recurrent High-Grade Glioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00064363
Recruitment Status : Completed
First Posted : July 9, 2003
Last Update Posted : March 8, 2012
National Cancer Institute (NCI)
Information provided by:
National Institutes of Health Clinical Center (CC)

Brief 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.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Drug: talampanel Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial Of Talampanel In Patients With Recurrent High-Grade Gliomas
Study Start Date : June 2003
Actual Study Completion Date : February 2007

Primary Outcome Measures :
  1. Progression at 6 months

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status

  • Karnofsky 60-100%

Life expectancy

  • More than 8 weeks


  • 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)


  • Bilirubin less than 2 times upper limit of normal (ULN)
  • SGOT less than 2 times ULN
  • No significant active hepatic disease


  • Creatinine less than 1.5 mg/dL OR
  • Creatinine clearance at least 60 mL/min
  • No significant active renal disease


  • No significant active cardiac disease


  • 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


Biologic therapy

  • At least 1 week since prior interferon or thalidomide
  • No concurrent anticancer immunotherapy


  • 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


  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy
  • No concurrent anticancer radiotherapy


  • See Disease Characteristics
  • Prior recent resection of recurrent or progressive disease allowed


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00064363

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United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
National Cancer Institute (NCI)
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Study Chair: Howard A. Fine, MD NCI - Neuro-Oncology Branch
Publications of Results:
Layout table for additonal information Identifier: NCT00064363    
Obsolete Identifiers: NCT00061685
Other Study ID Numbers: 030207
First Posted: July 9, 2003    Key Record Dates
Last Update Posted: March 8, 2012
Last Verified: March 2012
Keywords provided by National Institutes of Health Clinical Center (CC):
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
Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases