Anti-GD2 3F8 Antibody and Allogeneic Natural Killer Cells for High-Risk Neuroblastoma

Inclusion criteria

• Diagnosis of NB as defined by international criteria, i.e., histopathology (confirmed by the MSKCC Department of Pathology) or bone marrow metastases plus high urine catecholamine levels
• High-risk NB as defined by risk-related treatment guidelines and the International NB Staging System,57 i.e., stage 4 with (any age) or without (>365 days of age) MYCN amplification, MYCN-amplified stage 3 (unresectable; any age), or MYCN-amplified stage 4S.
• Patients must have a history of tumor progression or persistent disease or failure to achieve complete response following standard therapy.
• 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.
• Disease staging approximately within one month of treatment.
• Human anti-mouse antibody (HAMA) titer <1000 Elisa units/ml if applicable
• Available autologous stem cells: ≥2 x 106 CD34+ cells/kg
• Adequate cardiac function as measured by echocardiogram
• Eligible NK donor
• Signed informed consent indicating awareness of the investigational nature of this program.

Donor Eligibility

• Donor is blood-related and HLA-haploidentical to the recipient.
• Donor has undergone serologic testing for transmissible diseases as per blood banking guidelines for organ and tissue donors. Tests include but are not limited to: HepBsAg, HepBsAb, HepBcAb, HepC antibody, HIV, HTLV I and II, VZV, CMV and VDRL, West Nile Virus and Chagas screen. Donor must have normal negative test results for HIV, HTLV I and II, and West Nile Virus. Donor exposure to other viral pathogens will be discussed on a case-by-case basis by the investigators.
• Donor must be able to undergo leukopheresis for total volume of 10-15 liters.
• There is no age restriction for the donor.

Exclusion criteria

• Patients with CR/VGPR disease
• Existing severe major organ dysfunction, i.e., renal, cardiac, hepatic, neurologic, pulmonary, or gastrointestinal toxicity > or = to grade 3 except for hearing loss, alopecia, anorexia, nausea, hyperbilirubinemia and hypomagnesemia from TPN, which may be grade 3
• ANC should be >500/uL; platelet count >25K/uL.
• History of allergy to mouse proteins
• Active life-threatening infection
• HAMA titer >1000 Elisa units/ml
• Inability to comply with protocol requirements

Donor Exclusion Criteria

• Cardiac risk factors precluding ability to undergo leukopheresis
• Concurrent malignancy or autoimmune disease
• Donor is pregnant.