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
  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.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: talampanel
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial Of Talampanel In Patients With Recurrent High-Grade Gliomas

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Progression at 6 months [ Designated as safety issue: No ]

Study Start Date: June 2003
Study Completion Date: February 2007
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00064363

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
Investigators
Study Chair: Howard A. Fine, MD NCI - Neuro-Oncology Branch
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00064363     History of Changes
Obsolete Identifiers: NCT00061685
Other Study ID Numbers: 030207, 03-C-0207, CDR0000315425
Study First Received: July 8, 2003
Last Updated: March 7, 2012
Health Authority: United States: Federal Government

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:
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Nervous System Diseases

ClinicalTrials.gov processed this record on September 22, 2014