Talampanel in Treating Patients With Recurrent High-Grade Glioma

Brain and Central Nervous System Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00064363
• Other study ID #: 030207
• Secondary ID: 03-C-0207CDR0000
• Status: Completed
• Phase: Phase 2
• First received: July 8, 2003
• Last updated: March 7, 2012
• Start date: June 2003
• Est. completion date: February 2007

Study information

• Verified date: March 2012
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00061685

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• talampanel

Locations

Country	Name	City	State
United States	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
National Institutes of Health Clinical Center (CC)	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression at 6 months			No