Talampanel in Treating Patients With Recurrent High-Grade Glioma

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

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