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:
• •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.