AOST1421, A Phase II Study of Human-Mouse Chimeric Anti-Disialoganglioside Monoclonal Antibody ch14.18 (Dinutuximab, NSC# 764038, IND# 4308) in Combination with Sargramostim (GM-CSF) in Patients with Recurrent Osteosarcoma
Study ID: STU 122015-004
Summary
This study is a Phase ii trial to evaluate disease control rate as compared to historical experience in patients with recurrent pulmonary osteosarcoma who achieve a complete surgical resection following treatment with ch14.18 (dinutuximab) plus cytokine therapy. Based on data from nB clinical trials, it is well established that anti-GD2 therapy is most beneficial in the setting of minimal residual disease and hence in this trial, only patients with recurrent osteosarcoma who achieve a complete surgical remission are eligible.