Results of a phase I trial of a recombinant vaccinia virus that expresses carcinoembryonic antigen in patients with advanced colorectal cancer

Ann Surg Oncol. 1996 Sep;3(5):495-500. doi: 10.1007/BF02305769.


Background: The inadequacy of systemic treatments of advanced colorectal cancer has aroused interest in biologic therapy. Recent animal models have demonstrated the efficacy and safety of a recombinant vaccine that contains vaccinia and the gene for carcinoembryonic antigen (rV-CEA).

Methods: A phase I clinical trial of rV-CEA was conducted to assess vaccine toxicities, the maximum tolerated dosage, resulting immune activities, and tumour responses. A dose-escalation protocol was devised for three concentrations. Six patients per dosage were each to receive three vaccinations.

Results: Seventeen patients with advanced colorectal cancer received a total of 44 vaccinations. Mild local and systemic reactions-comparable to those seen with vaccinia alone-were observed and were typically associated with the first vaccination. No significant complications or deaths were caused by the rV-CEA. In particular, no autoimmune colitis developed, nor did leukopenia occur, despite some homology between CEA and leukocyte antigens. All three vaccine concentrations were equally well tolerated. Most patients demonstrated tumor progression by clinical and radiographic parameters and by CEA levels. Immune assays are pending.

Conclusions: This phase I trial demonstrated the safety of rV-CEA in patients with advanced colorectal cancer. Future clinical studies are warranted and will likely be influenced by investigations of the immune responses to the vaccine.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I

MeSH terms

  • Adenocarcinoma / immunology*
  • Adenocarcinoma / pathology
  • Adenocarcinoma / therapy
  • Adult
  • Aged
  • Cancer Vaccines / administration & dosage*
  • Cancer Vaccines / adverse effects
  • Carcinoembryonic Antigen / genetics
  • Carcinoembryonic Antigen / immunology*
  • Colorectal Neoplasms / immunology*
  • Colorectal Neoplasms / pathology
  • Colorectal Neoplasms / therapy
  • Dose-Response Relationship, Drug
  • Female
  • Gene Expression
  • Humans
  • Male
  • Middle Aged
  • Prognosis
  • Safety
  • Vaccines, Synthetic / administration & dosage*
  • Vaccines, Synthetic / adverse effects
  • Vaccinia virus / genetics
  • Vaccinia virus / immunology*


  • Cancer Vaccines
  • Carcinoembryonic Antigen
  • Vaccines, Synthetic