Phase II Trial of Phenylbutyrate Given as a Continuous Infusion in Pediatric Patients With Progressive or Recurrent CNS Malignancy
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.
Interventional
Primary Purpose: Treatment
Susan M. Blaney, MD
Study Chair
Texas Children's Cancer Center
United States: Federal Government
CDR0000068163
NCT00006238
November 2000
Name | Location |
---|---|
Children's Hospital of Philadelphia | Philadelphia, Pennsylvania 19104 |
University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
Children's National Medical Center | Washington, District of Columbia 20010-2970 |
Children's Hospital of Pittsburgh | Pittsburgh, Pennsylvania 15213 |
Texas Children's Cancer Center | Houston, Texas 77030-2399 |
UCSF Comprehensive Cancer Center | San Francisco, California 94115 |