AOST1421, A Phase II Study of Human-Mouse Chimeric Anti-Disialoganglioside Monoclonal Antibody ch14.18 (Dinutuximab, NSC#764038, IND# 4308) in Combination with GM-CSF in Patients with Recurrent Osteosarcoma (CTMS# 16-0013)
1.1 Primary Aims To determine the disease control rate in patients with completely resected recurrent osteosarcoma treated with ch14.18 (dinutuximab) in combination with sargramostim (GM-CSF) as compared to historical COG experience. 1.2 Secondary Aims 1.2.1 To characterize the pharmacokinetics of ch14.18 (dinutuximab) in patients with recurrent osteosarcoma in the proposed administration schedule. 1.2.2 To determine the occurrence of unacceptable toxicity (UT) in patients with recurrent osteosarcoma treated with ch14.18 (dinutuximab) in combination with sargramostim. 1.3 Exploratory Aims 1.3.1 To assess the relationship between probability of disease control and tumor GD2 expression. 1.3.2 To attempt banking of tumor samples for future research studies from patients enrolled on the study who undergo biopsy or resection of suspected metastatic disease recurrence while on protocol therapy or during the evaluation period. 1.3.3 To assess KIR and FcyR genotypes NKp30 isoforms and its circulating ligand, B7-H6 and their relationships to the probability of disease control. 1.3.4 To determine a descriptive profile of human anti-chimeric antibody (HACA) during immunotherapy.