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Talampanel in Treating Patients With Recurrent High-Grade Glioma

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00064363
First received: July 8, 2003
Last updated: March 7, 2012
Last verified: March 2012

July 8, 2003
March 7, 2012
June 2003
Not Provided
Progression at 6 months [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00064363 on ClinicalTrials.gov Archive Site
Not Provided
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Talampanel in Treating Patients With Recurrent High-Grade Glioma
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.

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
Brain and Central Nervous System Tumors
Drug: talampanel
Not Provided
Iwamoto FM, Kreisl TN, Kim L, Duic JP, Butman JA, Albert PS, Fine HA. Phase 2 trial of talampanel, a glutamate receptor inhibitor, for adults with recurrent malignant gliomas. Cancer. 2010 Apr 1;116(7):1776-82. doi: 10.1002/cncr.24957.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
February 2007
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00064363
030207, 03-C-0207, CDR0000315425
Not Provided
Not Provided
National Institutes of Health Clinical Center (CC)
National Cancer Institute (NCI)
Study Chair: Howard A. Fine, MD NCI - Neuro-Oncology Branch
National Institutes of Health Clinical Center (CC)
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP