Overview
Phenylacetate in Treating Children With Recurrent or Progressive Brain Tumors
Status:
Completed
Completed
Trial end date:
2004-09-01
2004-09-01
Target enrollment:
0
0
Participant gender:
All
All
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 phenylacetate in treating children with recurrent or progressive brain tumors.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Texas Children's Cancer CenterCollaborator:
National Cancer Institute (NCI)Treatments:
Phenylacetic acid
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed recurrent or progressive brain tumorsincluding the following: Anaplastic astrocytoma and glioblastoma multiforme Brain stem
glioma Medulloblastoma or primitive neuroectodermal tumors present in supratentorial or
posterior fossa locations Ependymoma Low grade gliomas Other Measurable or evaluable
disease by CT or MRI OR Histologically confirmed previously untreated glial tumors
including: Brain stem glioma Glioblastoma multiforme Measurable disease after surgery
PATIENT CHARACTERISTICS: Age: 2 to 21 Performance status: Karnofsky 50-100% (over 10 years
of age) Lansky 50-100% (under 10 years of age) Life expectancy: At least 8 weeks
Hematopoietic: Absolute neutrophil count greater than 1,000/mm3 Platelet count greater than
50,000/mm3 Hemoglobin greater than 7.0 g/dL Transfusion support allowed after bone marrow
transplantation or extensive radiation Hepatic: Bilirubin less than 1.5 mg/dL SGPT less
than 2 times normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance
greater than 60 mL/min Other: Not pregnant or nursing Fertile patients must use effective
contraception during and for 6 months after study No significant systemic illness including
infections No amino acidurias or organic acidemias
PRIOR CONCURRENT THERAPY: Biologic therapy: Recovered from all prior immunotherapy No
concurrent prophylactic hematopoietic growth factors Chemotherapy: At least 3 weeks since
prior myelosuppressive chemotherapy (6 weeks for nitrosourea) and recovered No other
concurrent cancer chemotherapy Endocrine therapy: Stable or decreasing dosage of
dexamethasone for intracranial pressure within 2 weeks of study entry No concurrent
dexamethasone used as an antiemetic Radiotherapy: At least 8 weeks since prior radiotherapy
to evaluable lesions and recovered Surgery: At least 4 months since prior radiosurgery
Other: No other concurrent investigational agents