Phase II Study of Anti-GD2 3F8 Antibody and GM-CSF for High-Risk Neuroblastoma

OBJECTIVES: * Determine the efficacy of sargramostim (GM-CSF) in enhancing monoclonal antibody 3F8-mediated ablation in patients with high-risk neuroblastoma. * Determine the prognostic impact of minimal residual bone marrow disease on relapse-free survival of patients treated with this regimen. * Compare the effects of short-term (2-hour intravenous) vs prolonged (subcutaneous release) daily GM-CSF on granulocyte activation, in order to establish the optimal route for tumor-cell kill in these patients. OUTLINE: This is an open-label study. Patients are stratified according to evaluable disease (yes \[primary refractory bone marrow disease\] vs no \[no evidence of disease\]). Patients receive sargramostim (GM-CSF) subcutaneously on days -5 to 4 and monoclonal antibody 3F8 IV over 0.5-1.5 hours on days 0-4. Treatment repeats every 3 weeks for 4 courses and then every 8 weeks for up to a total of 24 months in the absence of disease progression or unacceptable toxicity. Beginning after 2 courses of GM-CSF and monoclonal antibody 3F8, patients also receive oral isotretinoin twice daily on days 1-14 (when no monoclonal antibody 3F8 is administered). Treatment with isotretinoin repeats approximately every 28 days for 6 courses. PROJECTED ACCRUAL: A total of 340 patients will be accrued for this study.