SAFETY AND IMMUNOLOGICAL EVALUATION OF NY-ESO-1 PLASMID DNA (PPJV7611) CANCER

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This study in the targeted populaton of NSCLC patients expressing NY-ESO-1 expected to demonstrate that 1) NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine given by PMED can be safely administered using frequency, severity, and duration of treatment-related adverse effects as endpoints, 2) the vaccine elicits a cellular and humoral immune response to NY-ESO-1 by determination of NY-ESO-1 specific antibody, NY-ESO-1 specific CD8+ and CD4+ cells and delayed-type-hypersensitivity [DTH], and 3) to document tumor response in patients with measurable disease after receiving NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine administered by PMED.