New antibody combo offers hope for tough childhood cancer

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosis of NB as defined by a) histopathology (confirmed by the MSKCC Department of Pathology), or b) BM metastases or MIBG-avid lesion(s) plus high urine catecholamine levels. * Patients must have high-risk NB (including MYCNamplified stage 2/3/4/4S of any age and MYCN-nonamplified stage 4 in patients greater than 18 months of age) AND: * Phase I: Patients must have refractory or relapsed NB, resistant to standard therapy\*. \*For NB, standard therapy includes intensive induction chemotherapy, followed by a variety of consolidation or salvage therapies, depending on response. * Phase II: Patients must have primary or secondary refractory disease in BM, defined as morphologic evidence of NB in BM and/or abnormal 123I-MIBG uptake in osteomedullary sites, OR patients patients in ≥ 2nd CR patients are in ≥2nd CR * Patients must be older than 1 year of age. * Prior treatment with murine and humanized 3F8 is allowed. Patients with prior m3F8, hu3F8, ch14.18 or hu14.18 treatment must have a negative HAHA antibody titer. Human anti-mouse antibody (HAMA) positivity is allowed. * White blood cell count ≥1000/ul (phase I only) * Absolute neutrophil count ≥500/ul (phase I only) * Absolute lymphocyte count ≥500/ul (phase I only) * Platelet count ≥25,000/ul (phase I only) * No chemotherapy or immunotherapy for a minimum of three weeks prior to start of hu3F8 * Women of child-bearing potential must be willing to practice an effective method of birth control while on treatment * Signed informed consent indicating awareness of the investigational nature of this program. Exclusion Criteria: * Existing major organ dysfunction \> grade 2, with the exception of hearing loss and hematologic toxicity (defined as suppression of all subtypes of WBCs, RBCs, and platelets). * Active life-threatening infection. * Pregnant women or women who are breast-feeding. * Inability to comply with protocol requirements, including PK studies and genetic studies (phase I only) * History of allergy to mouse proteins. * Positive human anti-hu3F8 antibody (HAHA) titer