This is a small phase I study, the main purpose of which is to determine the safety of the vaccine and the immunologic responses of patients with metastatic KSA positive cancer to immunization with a vaccine consisting of alum precipitated liposomes with encapsulated lipid A and recombinant KSA antigen. The focus of the determination of immunologic responses is on the cytotoxic T-cell response to immunization. Clinical responses will also be evaluated. All patients receiving at least one immunization will be evaluated and reported. The goal is to evaluate six (6) patients who complete the full series of four (4) immunizations and have all of the required studies completed. If any patient does not meet this criteria, he will be replaced by an additional patient. If safety is established, we plan to use the data from this study to design a larger phase I/II study to gain additional information regarding safety and immunogenicity of the vaccine.
Showing the most recent 10 out of 570 publications