title: Intradermal injection of Newcastle disease virus-modified autologous melanoma cell lysate and interleukin-2 for adjuvant treatment of melanoma patients with resectable stage III disease.
abstract: BACKGROUND
  The value of active specific immunotherapy (ASI) for the treatment of solid tumours still has to be assessed. The objective was to test an autologous tumour cell vaccine for adjuvant treatment of stage III melanoma patients.
  
  
  METHODS
  After open vaccination of 12 patients, another 17 patients were recruited for a randomized double-blind trial comparing treatment with the vaccine (n = 9) and with a placebo (n = 8). Intracutaneous vaccinations were given postoperatively in weeks 2, 4, 6, 12, 24 and thereafter every 6 months if sufficient vaccine material was available. Patients were followed for 60-84 months.
  
  
  RESULTS
  Median disease-free survival time was 5 months for open-treated, 4 months for verum-treated and 6 months for placebo-treated patients. Corresponding median overall survival times were 30.5, 18 and 18.5 months, respectively. There were no remarkable differences between the verum and the placebo group.
  
  
  CONCLUSIONS
  Adjuvant treatment of melanoma patients with an autologous ASI vaccine did not show clinical efficacy in this cohort of melanoma patients.
authors.affiliation: Department of Dermatology of the Charité, Humboldt-University, Berlin, Germany. christiane.voit@t-online.de
authors.forename: Christiane
authors.initials: C
authors.lastname: Voit
authors.forename: Martina
authors.initials: M
authors.lastname: Kron
authors.forename: Markus
authors.initials: M
authors.lastname: Schwürzer-Voit
authors.forename: Wolfram
authors.initials: W
authors.lastname: Sterry
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017024:Chemotherapy, Adjuvant / Q000379:methods / Q000706:statistics & numerical data; D018572:Disease-Free Survival; D004311:Double-Blind Method; D005260:Female; D005858:Germany / Q000453:epidemiology; D006801:Humans; D007271:Injections, Intradermal; D007376:Interleukin-2 / Q000008:administration & dosage*; D008297:Male; D008545:Melanoma / Q000401:mortality* / Q000601:surgery / Q000628:therapy*; D008875:Middle Aged; D009367:Neoplasm Staging; D050130:Oncolytic Virotherapy / Q000379:methods / Q000706:statistics & numerical data*; D015990:Placebo Effect; D011379:Prognosis; D018570:Risk Assessment / Q000379:methods*; D012307:Risk Factors; D012878:Skin Neoplasms / Q000401:mortality* / Q000601:surgery / Q000628:therapy*; D016019:Survival Analysis; D015996:Survival Rate; D016896:Treatment Outcome; D014765:Viral Vaccines / Q000008:administration & dosage*
chemical_list: D007376:Interleukin-2; C424862:Newcastle disease virus vaccine MTH-68-H; D014765:Viral Vaccines