title: Pilot study of 1650-G: a simplified cellular vaccine for lung cancer.
abstract: BACKGROUND
  Cancer immunotherapy is a conceptually attractive since it is highly specific and can deal with disseminated disease with minimal impact on normal tissues. Early phase clinical trials have well established the ability of a variety of immunotherapeutic approaches to induce antigen specific immune responses in lung cancer patients. Although no immunotherapy is likely to be a panacea, recent data from randomized phase IIB studies offer promise of therapeutic activity in both early and late stage lung cancer.
  
  
  METHODS
  This report describes early clinical experience with vaccine 1650-G, an allogeneic cellular vaccine using granulocyte macrophage colony stimulating factor as an adjuvant. This nonrandomized pilot study was conducted at four sites in the Commonwealth of Kentucky with primary objective of determining biological activity in a relevant patient population; the use of similar antigen source, immunization schedule, and immunological assessment facilitated comparison to DC vaccines previously tested by our group.
  
  
  RESULTS
  Data indicates 1650-G is safe and generated a robust and unequivocal immunological response in 6/11 of immunized patients. The relative frequency and kinetics of the response appears similar to that achieved with DC vaccines (1650+autologous DC). The fact that this vaccine could be transported and delivered to cancer patients in community cancer clinics also fulfills an important objective of our research.
  
  
  CONCLUSIONS
  These findings provide critical foundation for further testing of this simple, and comparatively inexpensive multivalent NSCLC vaccine.
authors.affiliation: Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, University of Kentucky Chandler Medical Center, Lexington, KY 40536-0298, USA. eahirs2@uky.edu
authors.forename: Edward A
authors.initials: EA
authors.lastname: Hirschowitz
authors.forename: Alan
authors.initials: A
authors.lastname: Mullins
authors.forename: Dattatraya
authors.initials: D
authors.lastname: Prajapati
authors.forename: Thomas
authors.initials: T
authors.lastname: Baeker
authors.forename: Goetz
authors.initials: G
authors.lastname: Kloecker
authors.forename: Teresa
authors.initials: T
authors.lastname: Foody
authors.forename: Kristine
authors.initials: K
authors.lastname: Damron
authors.forename: Celia
authors.initials: C
authors.lastname: Love
authors.forename: John R
authors.initials: JR
authors.lastname: Yannelli
mesh_terms: D000230:Adenocarcinoma / Q000276:immunology / Q000473:pathology / Q000628:therapy*; D000368:Aged; D000369:Aged, 80 and over; D019496:Cancer Vaccines / Q000627:therapeutic use*; D018287:Carcinoma, Large Cell / Q000276:immunology / Q000473:pathology / Q000628:therapy*; D002289:Carcinoma, Non-Small-Cell Lung / Q000276:immunology / Q000473:pathology / Q000628:therapy*; D002294:Carcinoma, Squamous Cell / Q000276:immunology / Q000473:pathology / Q000628:therapy*; D005260:Female; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000008:administration & dosage; D006801:Humans; D007167:Immunotherapy; D008175:Lung Neoplasms / Q000276:immunology / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D010865:Pilot Projects; D011446:Prospective Studies; D015996:Survival Rate; D016896:Treatment Outcome; D014611:Vaccination
chemical_list: D019496:Cancer Vaccines; D016178:Granulocyte-Macrophage Colony-Stimulating Factor