Monoclonal Antibody 3F8 and Oral Etoposide for the Treatment of Neuroblastoma

Date de début de l'étude : 1 août 1999

DISEASE CHARACTERISTICS: High-risk neuroblastoma by: Histopathology OR Bone marrow involvement plus elevated urinary catecholamines Prior tumor progression on standard chemotherapy and poor long-term prognosis as indicated by 1 or more of the following: N-myc amplification in tumor cells Diploid chromosomal content plus lp loss of heterozygosity in tumor cells Distant skeletal metastases Unresectable primary tumor infiltrating across the midline More than 10% tumor cells in bone marrow Less than 30% chance of long-term progression-free survival Evaluable (microscopic marrow metastasis, elevated tumor markers, abnormal bone scan or MIBG or PET scan) but not measurable (CT scan, MRI) disease documented at least 4 weeks after completion of prior systemic therapy No rapidly progressive disease as defined by 1 or more of the following: Serum lactic dehydrogenase greater than 1.5 times upper limit of normal due to tumor An opiate requirement for pain from tumor Greater than 25% increase in tumor by successive imaging studies Life expectancy less than 8 weeks Second or subsequent remission after chemotherapy and/or radiotherapy allowed provided there is less than 30% chance of survival No prior myelodysplastic syndromes or leukemia PATIENT CHARACTERISTICS: Age: Not specified Performance status: Not specified Life expectancy: See Disease Characteristics At least 8 weeks Hematopoietic: Not specified Hepatic: No grade 3 or worse liver toxicity Renal: No grade 3 or worse renal toxicity Creatinine clearance at least 60 mL/min Cardiovascular: No grade 3 or worse cardiac toxicity Pulmonary: No grade 3 or worse pulmonary toxicity Other: Not pregnant No grade 3 or worse gastrointestinal toxicity No grade 3 or worse neurologic system toxicity No grade 4 hearing deficit No active life-threatening infection No prior exposure to mouse antibodies and human anti-mouse antibody greater than 1,000 ELISA units/mL No allergy to mouse proteins PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics