Multicenter phase II study of matured dendritic cells pulsed with melanoma cell line lysates in patients with advanced melanoma | Ribas et al. Journal of Translational Medicine 2010 8 89 http content 8 1 89 RESEARCH JOURNAL OF TRANSLATIONAL MEDICINE Open Access Multicenter phase II study of matured dendritic cells pulsed with melanoma cell line lysates in patients with advanced melanoma Antoni Ribas1 Luis H Camacho2 Sun Min Lee3 Evan M Hersh4 Charles K Brown5 Jon M Richards6 Maria Jovie Rodriguez2 Victor G Prieto2 John A Glaspy1 Denise K Oseguera1 Jackie Hernandez1 Arturo Villanueva1 Bartosz Chmielowski1 Peggie Mitsky3 Nadège Bercovici3 Ernesto Wasserman7 Didier Landais3 Merrick I Ross2 Abstract Background Several single center studies have provided evidence of immune activation and antitumor activity of therapeutic vaccination with dendritic cells DC in patients with metastatic melanoma. The efficacy of this approach in patients with favorable prognosis metastatic melanoma limited to the skin subcutaneous tissues and lung stages IIIc M1a M1b was tested in a multicenter two stage phase 2 study with centralized DC manufacturing. Methods The vaccine IDD-3 consisted 8 doses of autologous monocyte-derived matured DC generated in serum-free medium with granulocyte macrophage colony stimulating factor GM-CSF and interleukin-13 IL-13 pulsed with lysates of three allogeneic melanoma cell lines and matured with interferon gamma. The primary endpoint was antitumor activity. Results Among 33 patients who received IDD-3 there was one complete response CR two partial responses PR and six patients had stable disease SD lasting more than eight weeks. The overall prospectively defined tumor growth control rate was 27 90 confidence interval of 13-46 . IDD-3 administration had minimal toxicity and it resulted in a high frequency of immune activation to immunizing melanoma antigens as assessed by in vitro immune monitoring assays. Conclusions The administration of matured DC loaded with tumor lysates has significant immunogenicity and antitumor activity in patients with limited .
