Clinical Research Directory

Inclusion Criteria: * Diagnosis of NB as defined by international criteria,.e., histopathology (confirmed by the MSK Department of Pathology) or bone marrow metastases plus high urine catecholamine levels * High-risk NB as defined as any of the following: * Stage 4 with MYCN amplification (any age) * Stage 4 without MYCN amplification (\>1.5 years of age) * Stage 3 with MYCN amplification (unresectable; any age) * Stage 4S with MYCN amplification (any age) * Patients fulfill one of the following criteria: 1. Have evidence of soft tissue disease OR 2. If they only have osteomedullary disease at protocol enrollment, they should have: * Had previously received Hu3F8+GMCSF therapy AND have had less than a complete response to it OR * Had progressed progressive disease after their most recent anti-neuroblastoma therapeutic regimen * Patients must have evaluable (microscopic marrow metastasis, elevated tumor markers, positive MIBG or PET scans) or measurable (CT, MRI) disease documented after completion of prior systemic therapy. * Prior treatment with murine and hu3F8 is allowed. * Prior treatment with irinotecan or temozolomide is permitted. * Patients with prior m3F8, hu3F8, ch14.18 or hu14.18 treatment must have a negative HAHA antibody titer. Human anti-mouse antibody positivity is allowed. * Signed informed consent indicating awareness of the investigational nature of this program. Exclusion Criteria: * Patients with CR/VGPR disease * Existing severe major organ dysfunction, i.e., renal, cardiac, hepatic, neurologic, pulmonary, or gastrointestinal toxicity ≥ grade 3 except for hearing loss, alopecia, anorexia, nausea, and hypomagnesemia from TPN, which may be grade 3 * ANC \< 500/uL * Platelet count \<30K/uL * History of allergy to mouse proteins * Active life-threatening infection * Inability to comply with protocol requirements * Women who are pregnant or breast-feeding