Dendritic Cell Based Vaccine Therapy Of Melanoma

3077 Background: Vaccination with dendritic cells (DC) expressing tumor antigens is considered to be a possible strategy to induce anti-tumour immune responses in treatment of melanoma. Methods: 42 stage III and IV melanoma patients were enrolled into the study receiving autologous monocyte-derived DCs primed with autologous tumor lysate. DCs displayed mature phenotype. 75% of recruited pts had disease progression after conventional treatments modalities. Pts demographic characteristics wear: age 26–82 years (mean 54), male/female ratio = 24/18. Arm A included 17 pts treated with DC vaccine in therapeutic regimen (III stage - 2 pts, IV stage - 15 pts). Arm B consisted of 25 pts receiving DC vaccine after radical metastasectomy (III stage - 10 pts, IV stage - 15 pts). DC were administered s.c. q 2–4 weeks until disease progression in a dose of 1,0–5,0x10(6) cells. Pts who received = 4 vaccinations were evaluated, totally - 33 pts (79%) were considered evaluable. The vaccine therapy was evaluated for safety, tolerability and clinical effectiveness. Results. DCs vaccine was safe and well tolerated. Toxicity included flu-like syndrome (1 grade CTC), transitory hyperemia and itching in the sites of injections (1 grade CTC). 13 of 17 pts were evaluable in arm A, they received 210 vaccinations (from 4 to 21 per pts, mean 10,5). We observed 15,4% overall clinical response (1 complete and 1 partial response) and 38% stabilization of disease (lasting = 2 mos). 1- year survival, median survival were 42,5% and 9,5 mos, respectively. Follow-up 4–39+ mos. Among 20 evaluable pts in arm B who received 205 vaccinations (from 4 to 38 per pts, mean 15,8) median time to progression was 10 mos, 1-year survival - 84%, at a median follow- up of 12 mos (3–20+) disease free survival was 45%. Conclusion: DCs vaccine therapy is safe and lacks serious adverse effects. Melanoma pts with regional and distant metastasis demonstrated moderate clinical effectiveness in response to specific vaccine therapy. No significant financial relationships to disclose.