This phase II trial studies how well humanized monoclonal antibody 3F8 (Hu3F8) and sargramostim work in treating patients with bone cancer (osteosarcoma) that has come back (recurrent). Humanized monoclonal antibody 3F8 is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Colony-stimulating factors, such as sargramostim, may increase the number of granulocytes (kinds of white blood cells that are able to kill cancer cells). Sargramostim increases the number of other kinds of white blood cells that may help attack tumor cells. Sargramostim may also make humanized monoclonal antibody 3F8 more effective against osteosarcoma. Giving humanized monoclonal antibody 3F8 together with sargramostim may be an effective treatment for patients with osteosarcoma.
Additional locations may be listed on ClinicalTrials.gov for NCT02502786.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To evaluate event free survival (EFS) at 12 months after study enrollment in patients with pulmonary-only recurrent osteosarcoma (OS) treated with Hu3F8 (naxitamab) when combined with granulocyte-macrophage colony stimulating factor (GM-CSF).
SECONDARY OBJECTIVES:
I. To evaluate time to recurrence in patients with recurrent OS treated with Hu3F8 and GM-CSF.
II. To evaluate overall survival in patients with recurrent OS treated with Hu3F8 and GM-CSF.
III. To describe the toxicity associated with Hu3F8 and GM-CSF in patients with recurrent OS.
IV. To estimate EFS at 12 months in patients with extra-pulmonary recurrent OS.
V. To characterize the pharmacokinetics of naxitamab in patients with recurrent osteosarcoma.
OUTLINE:
Patients receive sargramostim subcutaneously (SC) on days -4 to 5 and naxitamab intravenously (IV) over 30-90 minutes on days 1, 3, and 5. Treatment repeats every 3-5 weeks for up to 5 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up monthly for 1 year, every 2 months for 1 year, every 4 months for 1 year, and then every 6 months for 1 year.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorFilemon Sorillo Dela Cruz