Status:
COMPLETED
Phase I and Pharmacokinetic Trial of Phenylbutyrate Given as a Continuous Infusion in Pediatric Patients With Refractory Malignancy
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Brain Neoplasms
Neuroblastoma
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
This is a pharmacokinetic trial. Patients receive phenylbutyrate through a central venous catheter for each 28 day cycle. The first several days of drug administration should be inpatient. Cycles may ...
Detailed Description
Phenylbutyrate is an aromatic fatty acid that is converted to phenylacetate in vivo by mitochondrial beta-oxidation to phenylacetate. Preclinical studies have shown that continuous exposure to phenyla...
Eligibility Criteria
Disease Characteristics:
Histologically proven cancer that is refractory to standard therapy.
Patients with neurofibromatosis having progressive inoperable plexiform neurofibromas with potential to cause significant morbidity are eligible.
Patients with brainstem gliomas histology may have histology requirements waived.
Patients without prior therapy are eligible if they have diseases with no available standard therapy.
Patients with evidence of bone marrow involvement by tumor, or a history of either bone marrow transplantation or extensive radiotherapy will be eligible, but inevaluable for hematologic toxicities.
Patients with greater than grade 2 neurocortical toxicity will be excluded.
PRIOR/CONCURRENT THERAPY:
Biologic Therapy: No concurrent hematopoietic growth factor.
Chemotherapy: No chemotherapy within 3 weeks of study.
No nitrosoursea within 6 weeks of study.
No concurrent chemotherapy allowed.
Must be on stable or decreasing dose of dexamethasone within 2 weeks of study.
Endocrine Therapy: Not specified.
Radiotherapy: No radiotherapy within 6 weeks of study.
Surgery: Not specified.
Other:
Patient must be recovered from toxic effects of all prior therapy.
Concurrent antibiotic therapy when appropriate.
Patient Characteristics:
Age: 2 to 21.
Performance Status: ECOG 0-2.
Life Expectancy: At least 8 weeks.
Hematopoietic (hematologic requirements below do not apply to patients with histologically confirmed bone marrow involvement or history of either bone marrow transplantation or extensive radiotherapy; these patients are inevaluable for hematologic toxicity):
Absolute granulocyte count (AGC) at least 1500/mm3.
Platelet count at least 100,000/mm3.
Hemoglobin at least 8 g/dL.
Hepatic:
Bilirubin no greater than 2 mg/Dl.
SGPT less than 2 times normal.
Renal:
Creatinine no greater than 1.5 mg/Dl OR
Creatinine clearance at least 60 Ml/min/square meter.
Other:
No systemic illness.
Not pregnant or nursing.
No amino acidurias or organic acidemias.
Key Trial Info
Start Date :
December 1 1996
Trial Type :
INTERVENTIONAL
End Date :
October 1 2000
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00001565
Start Date
December 1 1996
End Date
October 1 2000
Last Update
March 4 2008
Active Locations (1)
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1
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892