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Sponsors and Collaborators: |
Texas Children's Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00006238 |
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.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors |
Drug: sodium phenylbutyrate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase II Trial of Phenylbutyrate Given as a Continuous Infusion in Pediatric Patients With Progressive or Recurrent CNS Malignancy |
Study Start Date: | November 2000 |
OBJECTIVES:
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.
Ages Eligible for Study: | 2 Years to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed recurrent or progressive brain tumor after radiotherapy, chemotherapy, or bone marrow transplantation
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, California | |
UCSF Comprehensive Cancer Center | |
San Francisco, California, United States, 94143-0128 | |
United States, District of Columbia | |
Children's National Medical Center | |
Washington, District of Columbia, United States, 20010-2970 | |
United States, Minnesota | |
University of Minnesota Cancer Center | |
Minneapolis, Minnesota, United States, 55455 | |
United States, Pennsylvania | |
Children's Hospital of Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104-4318 | |
Children's Hospital of Pittsburgh | |
Pittsburgh, Pennsylvania, United States, 15213 | |
United States, Texas | |
Texas Children's Cancer Center | |
Houston, Texas, United States, 77030-2399 |
Study Chair: | Susan M. Blaney, MD | Texas Children's Cancer Center |
Study ID Numbers: | CDR0000068163, TCCC-H-6321, TCCC-GCRC-0692, NCI-O1-C-0028, NCI-T98-0042 |
Study First Received: | September 11, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00006238 History of Changes |
Health Authority: | United States: Federal Government |
childhood infratentorial ependymoma childhood supratentorial ependymoma childhood craniopharyngioma recurrent childhood brain tumor childhood central nervous system germ cell tumor childhood high-grade cerebral astrocytoma childhood oligodendroglioma childhood choroid plexus tumor |
childhood grade I meningioma childhood grade II meningioma childhood grade III meningioma recurrent childhood cerebellar astrocytoma recurrent childhood cerebral astrocytoma recurrent childhood medulloblastoma recurrent childhood visual pathway and hypothalamic glioma recurrent childhood ependymoma |
Choroid Plexus Neoplasms Astrocytoma 4-phenylbutyric acid Brain Tumor, Childhood Central Nervous System Neoplasms Ependymoma Recurrence |
Brain Neoplasms Medulloblastoma Craniopharyngioma Oligodendroglioma Meningioma Glioma Nervous System Neoplasms |
Neoplasms Neoplasms by Site Antineoplastic Agents 4-phenylbutyric acid Therapeutic Uses |
Nervous System Diseases Central Nervous System Neoplasms Pharmacologic Actions Nervous System Neoplasms |