Abstract
2526 Background: Vaccination with dendritic cell (DC)/tumor cell fusions can induce specific anti-tumor immunity in preclinical studies and has shown clinical activity. We report results of a fully enrolled, ongoing phase I/II study of electrofusion vaccine (EFV), comprised of allogeneic DCs (alloDC) and autologous tumor-derived cells administered subcutaneously to patients with Stage IV renal cell carcinoma (RCC). Methods: Tumors were processed and cryopreserved following acquisition from the primary or a metastatic site. Volunteer donor peripheral blood mononuclear cells were used to generate alloDC. At 6 week intervals, patients received up to 3 freshly prepared, irradiated EFV, within a constant dose range of 4 x 107 to 1 x 108 total cells. Study endpoints were safety, and tumor and immunologic response assessments. Results: Of the 30 enrolled patients, data are available on 21; 19 of the 21 were eligible for vaccination. The median age is 58 years (12 M, 9 F); mean number of metastatic sites is 2.4. ...
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