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
previously received Hu3F8+GMCSF therapy AND have had progressed while receiving
it or had an incomplete response

- 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 HAHA antibody
titer ≤1300 Elisa units/ml. 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