Anti-GD2 3F8 Antibody and Allogeneic Natural Killer Cells for High-Risk Neuroblastoma
Anti-GD2 3F8 Antibody and Allogeneic Natural Killer Cells for High-Risk Neuroblastoma
Funding Source - FDA OOPD FDR004128

 The goal of this study is to see if it is safe and feasible to give chemotherapy, natural
 killer (NK) cells, and an antibody called 3F8. The NK cells must come from a family member
 who shares half of the HLA proteins which are immune proteins important in transplant. NK
 cells are a type of white blood cell. They can recognize and kill abnormal cells in the body
 and can work together with antibodies to kill target cells. The antibody 3F8 specifically
 recognizes a protein present on the target cancer cell.
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.