AOST1321 - Phase 2 Study of Denosumab (IND# 127430, NSC# 744010), a RANK Ligand Antibody, for Recurrent or Refractory Osteosarcoma. An Intergroup NCTN Phase 2 Study (CTMS# 16-0051)
1.1.1 To determine whether denosumab therapy either increases the disease control rate at 4 months in patients with recurrent measurable osteosarcoma as compared to historical COG experience or denosumab therapy produces an objective response rate greater than 5% (Cohort 1).
1.1.2 To determine whether denosumab therapy increases the disease control rate at 12 months in patients with recurrent resected osteosarcoma as compared to historical COG experience (Cohort 2).
1.2.1 To investigate the pharmacokinetics (PK) and pharmacodynamics (PD) of denosumab in subjects with recurrent osteosarcoma.
1.2.2 To describe the tolerability of denosumab in subjects with recurrent osteosarcoma.
1.2.3 To report the disease control rate and objective response rate for patients with recurrent osteosarcoma limited to bone.
1.2.4 To investigate biological markers potentially associated with response to denosumab in patients with recurrent osteosarcoma.