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Phenylbutyrate in Treating Children With Progressive or Recurrent Cancer of the Central Nervous System

2014-08-27 03:57:25 | BioPortfolio

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of phenylbutyrate in treating children who have recurrent or progressive cancer of the central nervous system.

Description

OBJECTIVES:

- Determine the therapeutic efficacy of phenylbutyrate in terms of response rate and time to progression in children with recurrent or progressive CNS malignancy.

- Determine the toxicity of this regimen in these patients.

- Determine the correlation between serum steady state phenylbutyrate levels and response or toxicity in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to tumor histology (high grade glioma (anaplastic astrocytoma or glioblastoma multiforme) vs brain stem glioma vs medulloblastoma or primitive neuroectodermal tumors vs other).

Patients receive phenylbutyrate IV continuously on days 1-28. Treatment continues every 4 weeks for up to a maximum of 12 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 1 week.

PROJECTED ACCRUAL: A maximum of 120 patients (approximately 9-24 evaluable patients per stratum) will be accrued for this study within 2 years.

Study Design

Primary Purpose: Treatment

Conditions

Brain and Central Nervous System Tumors

Intervention

sodium phenylbutyrate

Location

UCSF Comprehensive Cancer Center
San Francisco
California
United States
94143-0128

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:57:25-0400

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