Study of Chemoimmunotherapy for High-Risk Neuroblastoma

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:

• Have evidence of soft tissue disease OR
• 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