Phenylacetate in Treating Children With Recurrent or Progressive Brain Tumors
|ClinicalTrials.gov Identifier: NCT00003241|
Recruitment Status : Completed
First Posted : September 10, 2004
Last Update Posted : June 26, 2013
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 phenylacetate in treating children with recurrent or progressive brain tumors.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Drug: phenylacetate||Phase 2|
OBJECTIVES: I. Determine the efficacy of phenylacetate in terms of response rate and time to progression in children with recurrent or progressive brain tumors, or with previously untreated poor prognosis brain tumors. II. Assess the toxicity of phenylacetate in these patients treated at the maximum tolerated dose. III. Determine the correlation between serum steady state phenylacetate levels and toxicity or response in these patients.
OUTLINE: Patients are stratified by histologic type (anaplastic astrocytoma and glioblastoma multiforme vs brain stem glioma vs medulloblastoma and primitive neuroectodermal tumors vs ependymoma vs low grade glioma vs others). Patients receive phenylacetate as a continuous intravenous infusion on days 1-28. Courses of treatment are given continuously without rest. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed weekly.
PROJECTED ACCRUAL: A total of 9-30 patients per stratum will be accrued for this study in 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase II Study of Phenylacetate in Pediatric Patients With Central Nervous System Tumors|
|Study Start Date :||May 1998|
|Actual Study Completion Date :||September 2004|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003241
|United States, California|
|Children's Hospital Los Angeles|
|Los Angeles, California, United States, 90027-0700|
|UCSF Cancer Center and Cancer Research Institute|
|San Francisco, California, United States, 94115-0128|
|United States, District of Columbia|
|Children's National Medical Center|
|Washington, District of Columbia, United States, 20010-2970|
|United States, Maryland|
|Pediatric Oncology Branch|
|Bethesda, Maryland, United States, 20892|
|United States, Ohio|
|Cleveland Clinic Cancer Center|
|Cleveland, Ohio, United States, 44195|
|United States, Texas|
|Texas Children's Cancer Center|
|Houston, Texas, United States, 77030-2399|
|Study Chair:||Lisa Bomgaars, MD||Texas Children's Cancer Center|