PHASE II TRIAL OF MONOCLONAL ANTIBODY 3F8 AND GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR (GM-CSF) FOR NEUROBLASTOMA

Date de début de l'étude : 1 février 1994

DISEASE CHARACTERISTICS: Neuroblastoma diagnosed by INSS criteria, i.e., either: Histologic proof of disease OR Tumor clumps in bone marrow plus elevated catecholamine levels Relapsed disease with poor long-term prognosis as indicated by at least one of the following: N-myc amplification in tumor cells Diploid chromosomal content in tumor cells Distant skeletal metastases Unresectable primary tumor crossing the midline Bone marrow with greater than 10% tumor cells Documentation of measurable progressive disease or biopsy- proven stable disease at least 4 weeks after prior systemic therapy required No rapidly progressive disease Poor risk neuroblastoma (but without measurable disease) not eligible for other neuroblastoma protocols PATIENT CHARACTERISTICS: Age: 2 to 21 Performance status: Not specified Life expectancy: Greater than 8 weeks Hematologic: Not specified Hepatic: No grade 3/4 toxicity LDH no greater than 1.5 times upper limit of normal Renal: Creatinine clearance at least 60 mL/min No grade 3/4 toxicity Cardiovascular: No grade 3/4 toxicity Pulmonary: No grade 3/4 toxicity Other: No grade 3/4 neurologic, gastrointestinal, or other organ toxicity except grade 3 hearing deficit No active life threatening infections No human antimouse antibody (HAMA) greater than 1,000 ELISA units/mL No allergy to mouse proteins No pain requiring opiates PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Standard chemotherapy to which disease is resistant or myeloablative therapy followed by disease recurrence required Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified