Autologous large multivalent immunogen vaccine in patients with metastatic melanoma and renal cell carcinoma

Arkadiusz Z. Dudek, Matthew F. Mescher, Ian Okazaki, Vivek T. Math, Xianghua Luo, Julie M. Curtsinger, Jeffrey S. Miller

Research output: Contribution to journalArticlepeer-review

24 Scopus citations

Abstract

OBJECTIVE: To evaluate the safety and activity of large multivalent immunogen (LMI), prepared by immobilizing autologous tumor cell plasma membrane on 5-μm 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.

Original languageEnglish (US)
Pages (from-to)173-181
Number of pages9
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Volume31
Issue number2
DOIs
StatePublished - Apr 2008

Keywords

  • Autologous vaccine
  • Large multivalent immunogen vaccine
  • Metastatic kidney cancer
  • Metastatic malignant melanoma

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