title: Autologous large multivalent immunogen vaccine in patients with metastatic melanoma and renal cell carcinoma.
abstract: OBJECTIVE
  To evaluate the safety and activity of large multivalent immunogen (LMI), prepared by immobilizing autologous tumor cell plasma membrane on 5-microm diameter silica beads, in patients with melanoma and renal cell carcinoma (RCC).
  
  
  METHODS
  Thirty patients with stage IV metastatic melanoma and 31 patients with stage IV RCC were randomly assigned to 1 of 3 trial arms and received monthly treatment with (1) LMI alone, (2) cyclophosphamide followed 8 days later with LMI, or (3) the same treatment as in arm 2 with IL-2 given for 5 days beginning 1 week after LMI administration.
  
  
  RESULTS
  No grade 4 toxicities were observed. For patients with melanoma, median overall survival time for all 30 patients was 20.4 months [95% confidence interval (CI): 8.0-not assessable], and median progression-free survival was 2.8 months (95% CI: 1.9-6.3). For patients with RCC, median overall survival exceeded 46.2 months (95% CI: 30.3-not assessable), and median progression-free survival was 12.2 months (95% CI: 4.6-not assessable). Two patients had a partial response to LMI treatment.
  
  
  CONCLUSIONS
  Based on our results that demonstrate the safety and tolerability of LMI vaccine, further development of this therapy is warranted to evaluate its clinical efficacy.
authors.affiliation: Division of Hematology, Oncology and Transplantation, University of Minnesota, 420 Delaware St. SE, MMC 480, Minneapolis, MN 55455, USA. dudek002@umn.edu
authors.forename: Arkadiusz Z
authors.initials: AZ
authors.lastname: Dudek
authors.forename: Matthew F
authors.initials: MF
authors.lastname: Mescher
authors.forename: Ian
authors.initials: I
authors.lastname: Okazaki
authors.forename: Vivek T
authors.initials: VT
authors.lastname: Math
authors.forename: Xianghua
authors.initials: X
authors.lastname: Luo
authors.forename: Julie M
authors.initials: JM
authors.lastname: Curtsinger
authors.forename: Jeffrey S
authors.initials: JS
authors.lastname: Miller
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000951:Antigens, Neoplasm / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000008:administration & dosage; D019496:Cancer Vaccines / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000473:pathology / Q000628:therapy*; D003131:Combined Modality Therapy; D003520:Cyclophosphamide / Q000008:administration & dosage; D005260:Female; D006801:Humans; D007376:Interleukin-2 / Q000008:administration & dosage; D007680:Kidney Neoplasms / Q000473:pathology / Q000628:therapy*; D008297:Male; D008545:Melanoma / Q000473:pathology / Q000628:therapy*; D008875:Middle Aged; D015999:Multivariate Analysis; D009362:Neoplasm Metastasis; D012878:Skin Neoplasms / Q000473:pathology / Q000628:therapy*; D016019:Survival Analysis
chemical_list: D000951:Antigens, Neoplasm; D000970:Antineoplastic Agents; D019496:Cancer Vaccines; D007376:Interleukin-2; D003520:Cyclophosphamide