Humanized Monoclonal Antibody 3F8 (Hu3F8) With Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in the Treatment of Recurrent Osteosarcoma
United States46 participantsStarted 2015-07
Plain-language summary
The purpose of this study is to find out what effect an antibody called Humanized 3F8 (Hu3F8) and a drug called GM-CSF have on the patient and whether it can keep the patient in remission longer and/or prevent recurrence of the disease.
Who can participate
Age range13 Months – 40 Years
SexALL
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Inclusion Criteria:
* Patients must have recurrent OS. OS must be verified by histopathology review by the site's Department of Pathology. (Patients registered at MSK must have pathology confirmed by MSK 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 ≥ 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 since major 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 for patients with Gilbert's syndrome who may be considered eligible if total bilirubin 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 limit of normal
* Adequate cardiac function as defined by a shortening fraction of ≥ 28% or an ejection fraction ≥ 50%
* Adequate pulmon…