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A Phase II Trial Of Talampanel In Patients With Recurrent High-Grade Gliomas

Phase 2
18 Years
Not Enrolling
Brain and Central Nervous System Tumors

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Trial Information

A Phase II Trial Of Talampanel In Patients With Recurrent High-Grade Gliomas


- 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

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.

Inclusion Criteria


- 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

- 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

- 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

- At least 4 weeks since prior investigational agents

- At least 4 weeks since prior cytotoxic therapy

- No other concurrent investigational agents

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression at 6 months

Safety Issue:


Principal Investigator

Howard A. Fine, MD

Investigator Role:

Study Chair

Investigator Affiliation:

NCI - Neuro-Oncology Branch


United States: Federal Government

Study ID:




Start Date:

June 2003

Completion Date:

February 2007

Related Keywords:

  • Brain and Central Nervous System Tumors
  • 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
  • Glioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms



Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support Bethesda, Maryland  20892-1182