This phase II trial studies how well humanized monoclonal antibody 3F8, sargramostim, and isotretinoin work in treating patients with high-risk neuroblastoma in first remission. Monoclonal antibodies, such as humanized monoclonal antibody 3F8, may interfere with the ability of tumor cells to grow and spread. Biological therapies, such as sargramostim, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as isotretinoin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving humanized monoclonal antibody 3F8, sargramostim, and isotretinoin may work better in treating patients with neuroblastoma.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03033303.
PRIMARY OBJECTIVE:
I. Assess the impact of humanized monoclonal antibody 3F8 (hu3F8)/sargramostim (granulocyte-macrophage colony-stimulating factor [GM-CSF]) on relapse-free survival (RFS) of high-risk (HR)-neuroblastoma (NB) patients in first complete remission (CR)/very good partial remission (VGPR).
SECONDARY OBJECTIVE:
I. Apply real-time quantitative reverse-transcription (qRT)-polymerase chain reaction (PCR) targeting a minimal residual disease (MRD) marker panel comprising of CCND1, GD2 synthase, ISL1, and PHOX2B to test the hypothesis that the MRD findings in bone marrow (BM) after the second cycle of hu3F8 + GM-CSF have significant correlation with outcome.
OUTLINE:
Patients receive sargramostim subcutaneously (SC) on days -4 to 5 and humanized monoclonal antibody 3F8 intravenously (IV) over 30-90 minutes on days 1, 3, and 5. Beginning day 5, cycles repeat after 2-4 weeks between cycles 1-4 and after 6-8 weeks between cycles 4-5 for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Beginning after the end of cycle 2 of sargramostim and humanized monoclonal antibody 3F8, patients receive isotretinoin orally (PO) for 14 days. Treatment with isotretinoin repeats after a minimum rest period of 14 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for up to 2 years.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorBrian Harris Kushner
