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

Antoni Ribas; Luis H. Camacho; Sun M. Lee; Evan M. Hersh; Charles K. Brown; Jon M. Richards; Maria J. Rodriguez; Victor G. Prieto; John A. Glaspy; Denise K. Oseguera; Jackie Hernandez; Arturo Villanueva; Bartosz Chmielowski; Peggie Mitsky; Nadège Bercovici; Ernesto Wasserman; Didier Landais; Merrick I. Ross

doi:10.1186/1479-5876-8-89

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

Antoni Ribas, Luis H. Camacho, Sun M. Lee, Evan M. Hersh, Charles K. Brown, Jon M. Richards, Maria J. Rodriguez, Victor G. Prieto, John A. Glaspy, Denise K. Oseguera, Jackie Hernandez, Arturo Villanueva, Bartosz Chmielowski, Peggie Mitsky, Nadège Bercovici, Ernesto Wasserman, Didier Landais, Merrick I. Ross

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36 Scopus citations

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 metastatic melanoma.Clinical trial registration: NCT00107159.

Original language	English (US)
Article number	89
Journal	Journal of translational medicine
Volume	8
DOIs	https://doi.org/10.1186/1479-5876-8-89
State	Published - Sep 27 2010

ASJC Scopus subject areas

General Biochemistry, Genetics and Molecular Biology

MD Anderson CCSG core facilities

Clinical Trials Office

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10.1186/1479-5876-8-89

Cite this

Ribas, A., Camacho, L. H., Lee, S. M., Hersh, E. M., Brown, C. K., Richards, J. M., Rodriguez, M. J., Prieto, V. G., Glaspy, J. A., Oseguera, D. K., Hernandez, J., Villanueva, A., Chmielowski, B., Mitsky, P., Bercovici, N., Wasserman, E., Landais, D., & Ross, M. I. (2010). Multicenter phase II study of matured dendritic cells pulsed with melanoma cell line lysates in patients with advanced melanoma. Journal of translational medicine, 8, Article 89. https://doi.org/10.1186/1479-5876-8-89

Ribas, A, Camacho, LH, Lee, SM, Hersh, EM, Brown, CK, Richards, JM, Rodriguez, MJ, Prieto, VG, Glaspy, JA, Oseguera, DK, Hernandez, J, Villanueva, A, Chmielowski, B, Mitsky, P, Bercovici, N, Wasserman, E, Landais, D & Ross, MI 2010, 'Multicenter phase II study of matured dendritic cells pulsed with melanoma cell line lysates in patients with advanced melanoma', Journal of translational medicine, vol. 8, 89. https://doi.org/10.1186/1479-5876-8-89

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title = "Multicenter phase II study of matured dendritic cells pulsed with melanoma cell line lysates in patients with advanced melanoma",

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 metastatic melanoma.Clinical trial registration: NCT00107159.",

author = "Antoni Ribas and Camacho, {Luis H.} and Lee, {Sun M.} and Hersh, {Evan M.} and Brown, {Charles K.} and Richards, {Jon M.} and Rodriguez, {Maria J.} and Prieto, {Victor G.} and Glaspy, {John A.} and Oseguera, {Denise K.} and Jackie Hernandez and Arturo Villanueva and Bartosz Chmielowski and Peggie Mitsky and Nad{\`e}ge Bercovici and Ernesto Wasserman and Didier Landais and Ross, {Merrick I.}",

note = "Funding Information: We would like to thank the staff at IDM Pharma Inc for their support in the conduct and immune monitoring analysis of this study. This work was previously presented as an oral presentation at the 2007 annual meeting of the American Society of Clinical Oncology (ASCO). AR was supported in part by the Jonsson Cancer Center Foundation (JCCF), The Fred L. Hartley Family Foundation and the Caltech-UCLA Joint Center for Translational Medicine.",

year = "2010",

month = sep,

day = "27",

doi = "10.1186/1479-5876-8-89",

language = "English (US)",

volume = "8",

journal = "Journal of translational medicine",

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TY - JOUR

T1 - Multicenter phase II study of matured dendritic cells pulsed with melanoma cell line lysates in patients with advanced melanoma

AU - Ribas, Antoni

AU - Camacho, Luis H.

AU - Lee, Sun M.

AU - Hersh, Evan M.

AU - Brown, Charles K.

AU - Richards, Jon M.

AU - Rodriguez, Maria J.

AU - Prieto, Victor G.

AU - Glaspy, John A.

AU - Oseguera, Denise K.

AU - Hernandez, Jackie

AU - Villanueva, Arturo

AU - Chmielowski, Bartosz

AU - Mitsky, Peggie

AU - Bercovici, Nadège

AU - Wasserman, Ernesto

AU - Landais, Didier

AU - Ross, Merrick I.

N1 - Funding Information: We would like to thank the staff at IDM Pharma Inc for their support in the conduct and immune monitoring analysis of this study. This work was previously presented as an oral presentation at the 2007 annual meeting of the American Society of Clinical Oncology (ASCO). AR was supported in part by the Jonsson Cancer Center Foundation (JCCF), The Fred L. Hartley Family Foundation and the Caltech-UCLA Joint Center for Translational Medicine.

PY - 2010/9/27

Y1 - 2010/9/27

N2 - 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.

AB - 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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U2 - 10.1186/1479-5876-8-89

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VL - 8

JO - Journal of translational medicine

JF - Journal of translational medicine

M1 - 89

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

Abstract

ASJC Scopus subject areas

MD Anderson CCSG core facilities

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