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

Persistent Link:
http://hdl.handle.net/10150/610196
Title:
Multicenter phase II study of matured dendritic cells pulsed with melanoma cell line lysates in patients with advanced melanoma
Author:
Ribas, Antoni; Camacho, Luis; Lee, Sun; Hersh, Evan; Brown, Charles; Richards, Jon; Rodriguez, Maria; Prieto, Victor; Glaspy, John; Oseguera, Denise; Hernandez, Jackie; Villanueva, Arturo; Chmielowski, Bartosz; Mitsky, Peggie; Bercovici, Nadege; Wasserman, Ernesto; Landais, Didier; Ross, Merrick
Affiliation:
University 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
Issue Date:
2010
Publisher:
BioMed Central
Citation:
Ribas et al. Journal of Translational Medicine 2010, 8:89 http://www.translational-medicine.com/content/8/1/89
Journal:
Journal of Translational Medicine
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)
Collection Information:
This item is part of the UA Faculty Publications collection. For more information this item or other items in the UA Campus Repository, contact the University of Arizona Libraries at repository@u.library.arizona.edu.
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.
EISSN:
1479-5876
DOI:
10.1186/1479-5876-8-89
Version:
Final published version
Additional Links:
http://www.translational-medicine.com/content/8/1/89

Full metadata record

DC FieldValue Language
dc.contributor.authorRibas, Antonien
dc.contributor.authorCamacho, Luisen
dc.contributor.authorLee, Sunen
dc.contributor.authorHersh, Evanen
dc.contributor.authorBrown, Charlesen
dc.contributor.authorRichards, Jonen
dc.contributor.authorRodriguez, Mariaen
dc.contributor.authorPrieto, Victoren
dc.contributor.authorGlaspy, Johnen
dc.contributor.authorOseguera, Deniseen
dc.contributor.authorHernandez, Jackieen
dc.contributor.authorVillanueva, Arturoen
dc.contributor.authorChmielowski, Bartoszen
dc.contributor.authorMitsky, Peggieen
dc.contributor.authorBercovici, Nadegeen
dc.contributor.authorWasserman, Ernestoen
dc.contributor.authorLandais, Didieren
dc.contributor.authorRoss, Merricken
dc.date.accessioned2016-05-20T09:00:49Z-
dc.date.available2016-05-20T09:00:49Z-
dc.date.issued2010en
dc.identifier.citationRibas et al. Journal of Translational Medicine 2010, 8:89 http://www.translational-medicine.com/content/8/1/89en
dc.identifier.doi10.1186/1479-5876-8-89en
dc.identifier.urihttp://hdl.handle.net/10150/610196-
dc.description.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.en
dc.language.isoenen
dc.publisherBioMed Centralen
dc.relation.urlhttp://www.translational-medicine.com/content/8/1/89en
dc.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)en
dc.titleMulticenter phase II study of matured dendritic cells pulsed with melanoma cell line lysates in patients with advanced melanomaen
dc.typeArticleen
dc.identifier.eissn1479-5876en
dc.contributor.departmentUniversity of California Los Angeles (UCLA), CA, USAen
dc.contributor.departmentMD Anderson Cancer Center, Houston, TX, USAen
dc.contributor.departmentIDM Pharma Inc. (IDM), Irvine, CA, USAen
dc.contributor.departmentArizona Cancer Center, Tucson, AZ, USAen
dc.contributor.departmentHillman Cancer Center, Pittsburgh, PA, USAen
dc.contributor.departmentLutheran General Cancer Care Centre, Park Ridge, IL, USAen
dc.contributor.departmentAAI Pharma Inc., San Antonio, TX, USAen
dc.identifier.journalJournal of Translational Medicineen
dc.description.collectioninformationThis item is part of the UA Faculty Publications collection. For more information this item or other items in the UA Campus Repository, contact the University of Arizona Libraries at repository@u.library.arizona.edu.en
dc.eprint.versionFinal published versionen
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