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.
  
  
  BACKGROUND
  NCT00107159.
authors.affiliation: University of California Los Angeles (UCLA), CA, USA. aribas@mednet.ucla.edu
authors.forename: Antoni
authors.initials: A
authors.lastname: Ribas
authors.forename: Luis H
authors.initials: LH
authors.lastname: Camacho
authors.forename: Sun Min
authors.initials: SM
authors.lastname: Lee
authors.forename: Evan M
authors.initials: EM
authors.lastname: Hersh
authors.forename: Charles K
authors.initials: CK
authors.lastname: Brown
authors.forename: Jon M
authors.initials: JM
authors.lastname: Richards
authors.forename: Maria Jovie
authors.initials: MJ
authors.lastname: Rodriguez
authors.forename: Victor G
authors.initials: VG
authors.lastname: Prieto
authors.forename: John A
authors.initials: JA
authors.lastname: Glaspy
authors.forename: Denise K
authors.initials: DK
authors.lastname: Oseguera
authors.forename: Jackie
authors.initials: J
authors.lastname: Hernandez
authors.forename: Arturo
authors.initials: A
authors.lastname: Villanueva
authors.forename: Bartosz
authors.initials: B
authors.lastname: Chmielowski
authors.forename: Peggie
authors.initials: P
authors.lastname: Mitsky
authors.forename: Nadège
authors.initials: N
authors.lastname: Bercovici
authors.forename: Ernesto
authors.initials: E
authors.lastname: Wasserman
authors.forename: Didier
authors.initials: D
authors.lastname: Landais
authors.forename: Merrick I
authors.initials: MI
authors.lastname: Ross
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019496:Cancer Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D045744:Cell Line, Tumor; D003713:Dendritic Cells / Q000166:cytology*; D005260:Female; D005434:Flow Cytometry; D006801:Humans; D007371:Interferon-gamma / Q000378:metabolism; D052118:Lysosomal-Associated Membrane Protein 1 / Q000378:metabolism; D052119:Lysosomal-Associated Membrane Protein 2 / Q000378:metabolism; D008297:Male; D008545:Melanoma / Q000378:metabolism / Q000473:pathology / Q000628:therapy*; D008875:Middle Aged; D009362:Neoplasm Metastasis; D016896:Treatment Outcome
chemical_list: D019496:Cancer Vaccines; D052118:Lysosomal-Associated Membrane Protein 1; D052119:Lysosomal-Associated Membrane Protein 2; D007371:Interferon-gamma