Phase III Randomized Study of Chimeric Antibody 14.18 (Ch14.18) in High Risk Neuroblastoma Following Myeloblative Therapy and Autologous Stem Cell Rescue
This study is being done to try and improve the likelihood that the cancer will not come back in children with high-risk neuroblastoma. Participants in this study have been undergoing treatment for high risk neuroblastoma. Children with high-risk neuroblastoma often respond to standard treatment at first, but there is a high risk that the cancer will come back. The purpose of this companion study is to evaluate an experimental treatment aimed at maintaining or improving theresponse to previous treatments. This study involves the use of an investigational biologic therapy, ch14.18, a monoclonal antibody. Monoclonal antibodies are proteins made in the lab, designed to attach to specific cancer cells. Ch14.18 was designed to attach to neuroblastoma cells and other cancer cells that have GD-2 on their cells. When ch14.18 attaches to the neuroblastoma cells, the body’s immune system is stimulated to attack and kill the neuroblastoma cells. Ch14.18 represents a new kind of cancer therapy that, unlike chemotherapy and radiation, targets the destruction of cancer cells without destroying nearby healthy cells.
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