title: A multi-peptide, dual-adjuvant telomerase vaccine (GX301) is highly immunogenic in patients with prostate and renal cancer.
abstract: BACKGROUND
  Anti-tumor vaccination is a new frontier in cancer treatment applicable to immunogenic neoplasms such as prostate and renal cancers. GX301 is a vaccine constituted by four telomerase peptides and two adjuvants, Montanide ISA-51 and Imiquimod.
  
  
  OBJECTIVE
  The aim of this study was to analyze safety and tolerability of GX301 in an open-label, phase I/II trial. Immunological and clinical responses were also evaluated as secondary endpoints.
  
  
  METHODS
  GX301 was administered by intradermally injecting 500 μg of each peptide (dissolved in Montanide ISA-51) in the skin of the abdomen. Imiquimod was applied as a cream at the injection sites. The protocol included 8 administrations at days 1, 3, 5, 7, 14, 21, 35, 63. Eligible patients were affected with stage IV prostate or renal cancer resistant to conventional treatments. Patients were clinically and immunologically monitored up to 6 months from the first immunization.
  
  
  RESULTS
  No grade 3-4 adverse events were observed. Evidence of vaccine-specific immunological responses was detected in 100 % of patients. Disease stabilization occurred in 4 patients. Prolonged progression-free survival and overall survival were observed in patients showing a full pattern of vaccine-specific immunological responses.
  
  
  CONCLUSIONS
  GX301 demonstrated to be safe and highly immunogenic. Further studies are needed to determine its clinical efficacy.
authors.affiliation: Centre of Excellence for Biomedical Research, University of Genoa, Viale Benedetto XV n. 7, 16132 Genoa, Italy.
authors.forename: Daniela
authors.initials: D
authors.lastname: Fenoglio
authors.forename: Paolo
authors.initials: P
authors.lastname: Traverso
authors.forename: Alessia
authors.initials: A
authors.lastname: Parodi
authors.forename: Laura
authors.initials: L
authors.lastname: Tomasello
authors.forename: Simone
authors.initials: S
authors.lastname: Negrini
authors.forename: Francesca
authors.initials: F
authors.lastname: Kalli
authors.forename: Florinda
authors.initials: F
authors.lastname: Battaglia
authors.forename: Francesca
authors.initials: F
authors.lastname: Ferrera
authors.forename: Stefania
authors.initials: S
authors.lastname: Sciallero
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Murdaca
authors.forename: Maurizio
authors.initials: M
authors.lastname: Setti
authors.forename: Alberto
authors.initials: A
authors.lastname: Sobrero
authors.forename: Francesco
authors.initials: F
authors.lastname: Boccardo
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Cittadini
authors.forename: Francesco
authors.initials: F
authors.lastname: Puppo
authors.forename: Domenico
authors.initials: D
authors.lastname: Criscuolo
authors.forename: Giorgio
authors.initials: G
authors.lastname: Carmignani
authors.forename: Francesco
authors.initials: F
authors.lastname: Indiveri
authors.forename: Gilberto
authors.initials: G
authors.lastname: Filaci
mesh_terms: D000276:Adjuvants, Immunologic; D000368:Aged; D000369:Aged, 80 and over; D000634:Aminoquinolines / Q000276:immunology; D000951:Antigens, Neoplasm / Q000737:chemistry / Q000276:immunology; D019496:Cancer Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D049109:Cell Proliferation; D003131:Combined Modality Therapy; D003602:Cytotoxicity, Immunologic; D006801:Humans; D000077271:Imiquimod; D007371:Interferon-gamma / Q000378:metabolism; D007680:Kidney Neoplasms / Q000276:immunology* / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D008297:Male; D008353:Mannitol / Q000031:analogs & derivatives / Q000276:immunology; D008875:Middle Aged; D009367:Neoplasm Staging; D009829:Oleic Acids / Q000276:immunology; D010455:Peptides / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D010641:Phenotype; D011471:Prostatic Neoplasms / Q000276:immunology* / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D019098:Telomerase / Q000737:chemistry / Q000276:immunology; D016896:Treatment Outcome
chemical_list: D000276:Adjuvants, Immunologic; D000634:Aminoquinolines; D000951:Antigens, Neoplasm; D019496:Cancer Vaccines; D009829:Oleic Acids; D010455:Peptides; C477385:montanide ISA 51; D008353:Mannitol; D007371:Interferon-gamma; D019098:Telomerase; D000077271:Imiquimod