Abstract
NY-ESO-1 is a cancer/testis antigen identified in an esophageal cancer using SEREX methodology. The antigen is expressed in a variety of tumors at various frequencies and has been shown to be highly immunogenic. We conducted a phase I clinical trial using NY-ESO-1 protein. A complex of cholesteryl hydrophobized pullulan (CHP) and NY-ESO-1 protein was administered subcutaneously every two weeks. The primary objectives were to evaluate safety and to assess immune responses. The secondary objective was to describe tumor response. The results show the material was tolerable and elicited NY-ESO-1 immunity. Furthermore, clinical response was observed in some patients. [Skin Cancer (Japan) 2009 ; 24 : 145-152]