Combination Chemotherapy, Monoclonal Antibody, and Natural Killer Cells in Treating Young Patients With Recurrent or Refractory Neuroblastoma

The mechanism of action of the CliniMACS Cell Selection System is based on magnetic-activated cell sorting (MACS). The CliniMACS device is a powerful tool for the isolation of many cell types from heterogeneous cell mixtures, (e.g. apheresis products). These can then be separated in a magnetic field using an immunomagnetic label specific for the cell type of interest, such as CD3+ human T cells.

"A maximum of 6 courses of therapy may be given on the following schedule:~* Courses 1, 3, and 5: Humanized anti-GD2 antibody + chemotherapy~* Courses 2, 4, and 6: Humanized anti-GD2 antibody + chemotherapy, with or without natural killer (NK) cells (depending on availability of appropriate NK donor)~* Humanized anti-GD2 antibody (hu14.18 K322A) dosage: 40 mg/m\^2)/dose, over 4 hours daily~* NK Cell dosage: minimum of 0.1 \* 10\^6 cells/kg; maximum of 400 \* 10\^6 CD45+ cells/kg, given once"

"Chemotherapy may include the following at the dosages shown below:~* cyclophosphamide: 400 mg/m\^2 IV days 1-5~* topotecan: 1.2 mg/m\^2 IV days 1-5~* temozolomide: 150 mg/m\^2 PO at least 1 hour before irinotecan~* irinotecan: 50 mg/m\^2 IV over 1 hour daily for 5 days~* carboplatin (AUC 8-dosing based on GFR), IV day 1 only~* ifosfamide: 2 g/m2 IV days 1-3~* etoposide: 100 mg/m2 days 1-3"

"Cytokines may be given at the following dosages:~* interleukin-2: 1 million units/m\^2 SQ beginning day 6 of each chemotherapy course and continued every other day for 6 doses~* GM-CSF: 250 mcg/m\^2/day beginning on day 7 or day 8 of chemotherapy course and continued daily through the nadir until ANC \>2,000/mm\^3"

NK cells from haploidentical family donor will be infused on day 7 or 8, depending on course. NK cells may be infused in either the inpatient or outpatient setting by a physician, Physician Assistant, Nurse Practitioner, or qualified RN. Careful monitoring and supportive care during NK cell infusion will be guided in part by the Standard Operating Procedures for Lymphocytes Infusions in the St. Jude Nursing Policy \& Procedure Manual.