Humanized Monoclonal Antibody 3F8 (Hu3F8) With Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in the Treatment of Recurrent Osteosarcoma

Inclusion Criteria:

- Patients must have recurrent OS. OS must be verified by histopathology review by the
site's Department of Pathology. (Patients registered at MSKCC must have pathology
confirmed by MSKCC Department of Pathology.)

- Patients must be in a ≥2nd complete remission as indicated by appropriate radiologic
evaluations at the time of study entry.

- Patients must be older than 1 year of age and less than or equal to 40 years of age.

- Prior therapy: ≥3 weeks should have elapsed since last cytotoxic therapy,
immunotherapy or radiation therapy. More than one week should have elapsed since major
surgery.

- Adequate hematopoietic function defined as:

- Absolute neutrophil count ≥ 500/ul

- Absolute lymphocyte count ≥ 500/ul

- Platelet count ≥ 50,000/ul (transfusion independent)

- Adequate hepatic function as defined by:

- Total bilirubin of ≤ 1.5 times upper limit of normal (exception is made for
patients with Gilbert's syndrome who may be considered eligible if total
bilirubin is ≤ 3 times upper limit of normal).

- AST of ≤ 3 times upper limit of normal

- ALT of ≤ 3 times upper limit of normal

- Adequate renal function as defined by a serum creatinine of ≤ 1.5 times upper limit of
normal

- Adequate cardiac function as defined by a shortening fraction of ≥ 28% or an ejection
fraction ≥ 50%

- Adequate performance status as defined by ECOG score of ≤ 2 or Karnofsky/Lansky score
≥ 50%

- Prior treatment with other anti-GD2 antibodies is allowed (prior treatment with hu3F8
is NOT allowed), but HAHA antibody titer must be ≤1300 Elisa units/mL

- 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:

- Patients with OS in first complete remission.

- Presence of overt metastatic disease at any site.

- Active life-threatening infection.

- Pregnant women or women who are breast-feeding.

- Inability to comply with protocol requirements.