Phase I and Pharmacokinetic Trial of Paclitaxel (Taxol) Given as a 3-Hour Infusion in Pediatric Patients With Refractory Malignancy

Date de début de l'étude : 1 septembre 1994

DISEASE CHARACTERISTICS: Histologically confirmed cancer (including leukemia) that is: Refractory to standard therapy (objective disease progression required) OR For which no standard therapy exists and patient is ineligible for potentially curative surgery. PRIOR/CONCURRENT THERAPY: Recovery from the toxic effects of prior therapy required. Biologic Therapy: Not specified. Chemotherapy: No prior taxanes. At least 3 weeks since myelosuppressive therapy (6 weeks since nitrosourea). Endocrine Therapy: Not specified. Radiotherapy: Prior extensive craniospinal or pelvic irradiation allowed. Surgery: Ineligible for potential curative surgery. Other: Prior bone marrow transplant allowed. PATIENT CHARACTERISTICS: Age: Over 1 to 21; Performance status: ECOG 0-2; Life expectancy: At least 8 weeks. Hematopoietic: (except with leukemia, bone marrow involvement, history of bone marrow transplantation, or extensive prior radiotherapy). Absolute granulocyte count at least 1,500/mm(3); Platelet count at least 100,000/mm(3); Hemoglobin at least 8.0 g/dL. Hepatic: Bilirubin no greater than 1.5 mg/dL; AST less than 2 times normal. Renal: Creatinine no greater than 1.5 mg/dL OR; Creatinine clearance at least 60 mL/min per square meter. OTHER: No concurrent anticonvulsant therapy. No grade 2 or worse neuropathy. No significant systemic illness (e.g., infection) that could compromise drug excretion or confuse assessment of toxicity. Not pregnant or nursing.