title: Randomized phase II study of IL-2 with or without an allogeneic large multivalent immunogen vaccine for the treatment of stage IV melanoma.
abstract: OBJECTIVE
  To evaluate the activity of interleukin-2 (IL-2) in combination with allogeneic large multivalent immunogen (LMI) vaccine, prepared by immobilizing SK23-CD80 melanoma cell line plasma membrane on 5-μm-diameter silica beads, in patients with melanoma.
  
  
  METHODS
  Twenty-one patients with metastatic melanoma were randomly assigned to an IL-2 alone control group or an IL-2 plus LMI vaccine treatment group. The primary objective was to evaluate the progression-free survival (PFS) of each group. Secondary clinical objectives included median overall survival (OS) and 1- and 2-year rates of OS.
  
  
  RESULTS
  Treatment was very well tolerated. Median PFS was no different between the treatment arm (2.20 mo) and control arm (1.95 mo). Median OS was also similar for the treatment arm (11.89 mo) and control arm (9.97 mo).
  
  
  CONCLUSIONS
  This study failed to demonstrate that allogeneic LMI vaccine and low-dose IL-2 improved survival in patients with melanoma as compared with low-dose IL-2 alone.
authors.affiliation: *Division of Hematology, Oncology and Transplantation †Department of Laboratory Medicine and Pathology, Center for Immunology, University of Minnesota ‡University of Minnesota Comprehensive Cancer Center, Minneapolis, MN.
authors.forename: Gautam
authors.initials: G
authors.lastname: Jha
authors.forename: Jeffrey S
authors.initials: JS
authors.lastname: Miller
authors.forename: Julie M
authors.initials: JM
authors.lastname: Curtsinger
authors.forename: Yan
authors.initials: Y
authors.lastname: Zhang
authors.forename: Mathew F
authors.initials: MF
authors.lastname: Mescher
authors.forename: Arkadiusz Z
authors.initials: AZ
authors.lastname: Dudek
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D019496:Cancer Vaccines / Q000276:immunology* / Q000627:therapeutic use*; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007376:Interleukin-2 / Q000008:administration & dosage / Q000627:therapeutic use*; D053208:Kaplan-Meier Estimate; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000276:immunology* / Q000473:pathology; D008875:Middle Aged; D009367:Neoplasm Staging; D012107:Research Design; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000276:immunology* / Q000473:pathology; D016896:Treatment Outcome; D000096142:Cutaneous Malignant Melanoma
chemical_list: D000970:Antineoplastic Agents; D019496:Cancer Vaccines; D007376:Interleukin-2