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Phase 2 Trial Using Talampanel in Patients With Recurrent High Grade Gliomas

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: NCT00062504
Recruitment Status : Terminated
First Posted : June 12, 2003
Last Update Posted : May 23, 2011
National Cancer Institute (NCI)
Information provided by:
Teva Pharmaceutical Industries

Brief Summary:
To analyze the effect of Talampanel on progression free survival in patients with recurrent high grade gliomas.

Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme Anaplastic Astrocytoma Anaplastic Oligodendroglioma Anaplastic Mixed Oligoastrocytoma Drug: Talampanel Phase 2

Detailed Description:
To determine the efficacy of Talampanel in patients with recurrent malignant glioma as measured by 6-month progression survival, as well as to obtain preliminary information regarding the spectrum of toxicities of the drug among this patient population.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: A Phase II Trial of Talampanel in Patients With Recurrent High-Grade Gliomas.
Study Start Date : July 2003
Actual Primary Completion Date : January 2006
Actual Study Completion Date : April 2006

Arm Intervention/treatment
Experimental: 1
Valproic: 10mg TID week 1, 25mg TID week 2, 35mg week 3
Drug: Talampanel
10mg, 25 mg, 35 mg, 50 mg, 75mg TID for 3 weeks

Experimental: 2
Non-enzyme-inducing anti-epileptic drugs: 25mg TID week 1, 35mg week 2, 50mg week 3
Drug: Talampanel
10mg, 25 mg, 35 mg, 50 mg, 75mg TID for 3 weeks

Experimental: 3
Enzyme-inducing anti-epileptic drugs: 35mg TID week 1, 505mg week 2, 75mg week 3
Drug: Talampanel
10mg, 25 mg, 35 mg, 50 mg, 75mg TID for 3 weeks

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


  1. Patients with histologically proven intracranial malignant glioma will be eligible for this protocol. Malignant glioma include glioblastoma multiforme (GBM), anaplastic astrocytoma (AA), anaplastic oligodendroglioma (AO), anaplastic mixed oligoastrocytoma (AMO), or malignant astrocytoma NOS (not otherwise specified).
  2. Patients must have unequivocal evidence for tumor progression by MRI or CT scan. This scan should be performed within 14 days prior to registration and on a steroid dosage that has been stable for at least 5 days.
  3. Patients having undergone recent resection of recurrent or progressive tumor will be eligible as long as all of the following conditions apply:

    1. They have recovered from the effects of surgery.
    2. Residual disease following resection of recurrent tumor is not mandated for eligibility into the study. To best assess the extent of residual disease post-operatively, a CT/ MRI should be done:

      • no later than 96 hours in the immediate post-operative period or
      • at least 4 weeks post-operatively, and
      • within 14 days of registration, and
      • on a steroid dosage that has been stable for at least 5 days.
  4. If the 96-hour scan is more than 21 days before registration, the scan needs to be repeated.
  5. Patients must have failed prior radiation therapy and must have an interval of greater than or equal to 4 weeks from the completion of radiation therapy to study entry.
  6. All patients must sign an informed consent indicating that they are aware of the investigational nature of this study.
  7. Patients must be > 18 years old, and with a life expectancy > 8 weeks.
  8. Patients must have a Karnofsky performance status of > 60.
  9. Patients must have recovered from the toxic effects of prior therapy: 4 weeks from any investigational agent, 4 weeks from prior cytotoxic therapy, two weeks from vincristine, 6 weeks from nitrosoureas, 3 weeks from procarbazine administration, and 1 week for non-cytotoxic agents, e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc. (radiosensitizer does not count).
  10. Patients must have adequate bone marrow function (ANC > 1,200/mm3, platelet count of > 100,000/mm3, and hemoglobin > 10 gm/dl), adequate liver function (SGOT and bilirubin < 2 times ULN), and adequate renal function (serum creatinine < 1.5 mg/dL otherwise a measured 24-hour creatinine clearance > 60 cc/min) before starting therapy. These tests must be performed within 14 days prior to registration.
  11. Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patients' ability to tolerate this therapy.
  12. This study was designed to include women and minorities, but was not designed to measure differences of intervention effects.
  13. Patients must not have active infection requiring IV antibiotics.
  14. Patients must not be pregnant or nursing, and all patients (both men and women) must be willing to practice birth control during and for 2 months after treatment with Talampanel. Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner).

Exclusion Criteria

  1. Patients who, in the view of the treating physician, have significant active cardiac, hepatic, renal, or psychiatric diseases are ineligible that would significantly increase the risk of using talampanel.
  2. No concurrent use of other standard chemotherapeutics or investigative agents.
  3. Patients known to have an active, life-threatening malignancy.
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Responsible Party: Rivka Kreitman, Ph.D., Vice President, Innovative Research and Development, Teva Neuroscience Identifier: NCT00062504    
Other Study ID Numbers: IXR-205-21-189
First Posted: June 12, 2003    Key Record Dates
Last Update Posted: May 23, 2011
Last Verified: May 2011
Additional relevant MeSH terms:
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Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue