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Multicenter phase II study of matured dendritic cells pulsed with melanoma cell line lysates in patients with advanced melanoma.

Ribas, Antoni and Camacho, Luis H and Lee, Sun Min and Hersh, Evan M and Brown, Charles K and Richards, Jon M and Rodriguez, Maria Jovie and Prieto, Victor G and Glaspy, John A and Oseguera, Denise K and Hernandez, Jackie and Villanueva, Arturo and Chmielowski, Bartosz and Mitsky, Peggie and Bercovici, Nadège and Wasserman, Ernesto and Landais, Didier and Ross, Merrick I (2010) Multicenter phase II study of matured dendritic cells pulsed with melanoma cell line lysates in patients with advanced melanoma. J Transl Med, 8. 89 - ?.

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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 metastatic melanoma. CLINICAL TRIAL REGISTRATION: NCT00107159.


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Item Type: Article
Status: Published
CreatorsEmailPitt UsernameORCID
Ribas, Antoni
Camacho, Luis H
Lee, Sun Min
Hersh, Evan M
Brown, Charles K
Richards, Jon M
Rodriguez, Maria Jovie
Prieto, Victor G
Glaspy, John A
Oseguera, Denise K
Hernandez, Jackie
Villanueva, Arturo
Chmielowski, Bartosz
Mitsky, Peggie
Bercovici, Nadège
Wasserman, Ernesto
Landais, Didier
Ross, Merrick I
Centers: Other Centers, Institutes, Offices, or Units > Hillman Cancer Center
Date: 27 September 2010
Date Type: Acceptance
Journal or Publication Title: J Transl Med
Volume: 8
Page Range: 89 - ?
DOI or Unique Handle: 10.1186/1479-5876-8-89
Refereed: Yes
Uncontrolled Keywords: Adult, Aged, Aged, 80 and over, Cancer Vaccines, Cell Line, Tumor, Dendritic Cells, Female, Flow Cytometry, Humans, Interferon-gamma, Lysosomal-Associated Membrane Protein 1, Lysosomal-Associated Membrane Protein 2, Male, Melanoma, Middle Aged, Neoplasm Metastasis, Treatment Outcome
Date Deposited: 14 Nov 2016 20:21
Last Modified: 20 Dec 2018 00:55


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