Talampanel in Treating Patients With Recurrent High-Grade Glioma

Sponsor

National Institutes of Health Clinical Center (CC) (NIH)

Overall Status

Completed

CT.gov ID

NCT00064363

Collaborator

National Cancer Institute (NCI) (NIH)

Location

44.1

Duration (Months)

Study Details

Study Description

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

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.

Study Design

Study Type:

Interventional

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 :

Jun 1, 2003

Actual Study Completion Date :

Feb 1, 2007

Outcome Measures

Primary Outcome Measures

Progression at 6 months []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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