Humanized 3F8 Monoclonal Antibody (Hu3F8) When Combined With Interleukin-2 in Patients With High-Risk Neuroblastoma and GD2-positive Solid Tumors

Inclusion Criteria

• •Patients must have either (1) a diagnosis of NB as defined by international criteria,84 i.e., histopathology (confirmed by the MSKCC Department of Pathology) or BM metastases plus high urine catecholamine levels, or (2) a tumor that is GD2-positive.
• •Patients must have either (1) refractory or relapsed high-risk NB (including MYCN-amplified stage 2/3/4/4S of any age and MYCN-nonamplified stage 4 in patients greater than 18 months of age)resistant to standard therapy\*, or (2) refractory or relapsed GD2-positive tumor after receiving available life-prolonging therapies.
• •\*For NB, standard therapy generally includes 5-8 cycles of high dose induction chemotherapy followed by resection of gross residual tumor, with or without myeloablative chemotherapy with peripheral blood stem cell rescue and radiation therapy to the primary site. There are also salvage chemotherapy regimens for residual disease after standard induction therapy or for relapsed NB. Some examples of these chemotherapy combinations are: high-dose cyclophosphamide, topotecan and vincristine; high-dose cyclophosphamide, irinotecan and vincristine; irinotecan and temozolomide; or ifosfamide, carboplatin and etoposide.
• •Patients must be older than 1 year of age.
• •Prior treatment with murine 3F8 is allowed. Patients with prior m3F8, hu3F8, ch14.18 or hu14.18 treatment must have HAHA antibody titer less than or = to 1300 Elisa units/ml
• •White blood cell count ≥1000/ul
• •Absolute neutrophil count ≥500/ul
• •Absolute lymphocyte count ≥500/ul
• •Platelet count ≥25,000/ul
• •No chemotherapy or immunotherapy for a minimum of three weeks prior to study enrollment
• •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.