Phase I and Pharmacokinetic Trial of Phenylbutyrate Given as a Continuous Infusion in Pediatric Patients With Refractory Malignancy

You may be eligible if

• 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 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.