3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Primary Refractory Neuroblastoma in Bone Marrow

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.

- High-risk NB as defined by risk-related treatment guidelines1 and the International NB
Staging System,89 i.e., stage 4 with (any age) or without (> or = to 18 months of age)
MYCN amplification or MYCN-amplified stage 4S.

- Patients have primary refractory disease limited to BM, i.e., high-risk NB (defined
above) resistant to standard therapy, as evidenced by incomplete response in BM, but
no measurable MIBG-avid soft tissue tumor assessable for response and no progressive
disease.

- Signed informed consent indicating awareness of the investigational nature of this
program.

Exclusion Criteria:

- Creatinine > 3.0 mg/dL

- ALT, AST and Alkaline Phosphatase > 5.0 times the upper limit of normal

- Bilirubin > 3.0 mg/dL

- Patients with grade 3 or higher toxicities (using the CTCAE v 4.0) related to cardiac,
neurological, pulmonary or gastrointestinal function as determined by physical exam.
Patients must have normal blood pressure for age.

- Progressive disease

- History of allergy to mouse proteins.

- Active life-threatening infection.

- Human anti-mouse antibody (HAMA) titer >1000 Elisa units/ml.

- Inability to comply with protocol requirements.