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 thesite's Department of Pathology. (Patients registered at MSK must have pathologyconfirmed by MSK Department of Pathology.)

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

• Patients must be ≥ 1 year of age and ≤ to 40 years of age at the time of enrollment.

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

NOTE: Minor surgery (e.g. minor biopsy, central venous catheter placement, shunt revision) is permitted within 1 week prior to enrollment)

• 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 forpatients with Gilbert's syndrome who may be considered eligible if totalbilirubin is ≤ 3 times upper limit of normal).

• AST (SGOT) of ≤ 3 times upper limit of normal

• ALT (SGPT) of ≤ 3 times upper limit of normal

• Adequate renal function as defined by a serum creatinine of ≤ 1.5 times upper limitof normal

• Adequate cardiac function as defined by a shortening fraction of ≥ 28% or anejection fraction ≥ 50%

• Adequate pulmonary function as defined by no evidence of dyspnea at rest at nohistory of exercise intolerance

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

• Prior treatment with other anti-GD2 antibodies is allowed (prior treatment withHu3F8 is NOT allowed), but HAHA antibody titer must be negative

• Women of child-bearing potential must be willing to practice an effective method ofbirth control while on treatment

• Signed informed consent indicating awareness of the investigational nature of thisprogram

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.