- Diagnosis of NB as defined by international criteria,.e., histopathology (confirmed
by the MSKCC Department of Pathology) or bone marrow metastases plus high urine
- High-risk NB as defined by risk-related treatment guidelines1 and the International
NB Staging System, 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
- 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
- Prior treatment with murine and hu3F8 is allowed. 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.
- Eligible NK donor
- Children and adults are eligible
- Signed informed consent indicating awareness of the investigational nature of this
Donor Inclusion Criteria
- 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:
Hepatitis B Surface Antigen, Hepatitis B Surface Antibody, Hepatitis B Core Antibody,
Hepatitis C antibody, Epstein-Barr Virus Antibody, HIV, HTLV I and II, Varicella
Zoster (Herpes Zoster), Herpes Simplex Antibody, Cytomegalovirus Antibodies, Syphilis
(RPR profile) for adolescents and adults, measles for pediatric patients, West Nile
Virus, Chagas screen, and Toxoplasma antibodies.
- Donor must be able to undergo leukopheresis for total volume of 10-15 liters.
- There is no age restriction for the donor.
- 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, hyperbilirubinemia and hypomagnesemia from TPN, which may be grade
- ANC should be >500/uL
- Platelet count >75K/uL.
- History of allergy to mouse proteins
- Active life-threatening infection
- Inability to comply with protocol requirements
- Women who are pregnant or breast-feeding
Donor Exclusion Criteria:
- Cardiac risk factors precluding ability to undergo leukopheresis
- Concurrent malignancy or autoimmune disease
- Donor is pregnant
Minimum Eligible Age: N/A
Maximum Eligible Age: N/A
Eligible Gender: Both