Multicenter phase II study of matured dendritic cells pulsed with melanoma cell line lysates in patients with advanced melanoma
AffiliationUniversity of California Los Angeles (UCLA), CA, USA
MD Anderson Cancer Center, Houston, TX, USA
IDM Pharma Inc. (IDM), Irvine, CA, USA
Arizona Cancer Center, Tucson, AZ, USA
Hillman Cancer Center, Pittsburgh, PA, USA
Lutheran General Cancer Care Centre, Park Ridge, IL, USA
AAI Pharma Inc., San Antonio, TX, USA
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CitationRibas et al. Journal of Translational Medicine 2010, 8:89 http://www.translational-medicine.com/content/8/1/89
Rights© 2010 Ribas et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0)
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AbstractBACKGROUND: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 metastatic melanoma.CLINICAL TRIAL REGISTRATION:NCT00107159.
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