A pilot safety trial investigating a vector-based vaccine targeting carcinoembryonic antigen in combination with radiotherapy in patients with gastrointestinal malignancies metastatic to the liver

Expert Opin Biol Ther. 2011 Nov;11(11):1409-18. doi: 10.1517/14712598.2011.615741. Epub 2011 Aug 28.


Objective: Previous studies have demonstrated the ability of non-lethal doses of radiation to alter the phenotype of tumor cells to facilitate immune mediated killing. This pilot study evaluated the tolerability of a vector-based vaccine targeting carcinoembryonic antigen (CEA) in combination with radiation therapy in patients with gastrointestinal malignancies metastatic to the liver.

Methods: Patients enrolled had progressive CEA(+) tumors with metastatic liver lesions. Patients had received a median of three previous chemotherapy regimens, with a median of 2 months since their last chemotherapy regimen. Only 58% had metastatic disease limited to the liver. Vaccination commenced day 1 with biweekly boosters and split-course radiation (total 32 Gy) starting on day 21. Blood was collected at baseline and day 91 for immunological analysis.

Results/conclusion: A total of 12 patients were enrolled. There were no grade 3 or greater toxicities or grade 2 or greater hepatic toxicities. Median time on-study was 3 months, with the longest time on treatment being 5 months (n = 2). Immunological analysis was limited to two patients; neither showed an increase above baseline in CEA-specific T cells post-therapy. CEA/TRICOM vaccination in combination with low-dose radiation therapy is safe. There was limited evidence of activity in this patient population.

Publication types

  • Clinical Trial
  • Research Support, N.I.H., Intramural

MeSH terms

  • Adult
  • Aged
  • Cancer Vaccines / adverse effects
  • Cancer Vaccines / therapeutic use*
  • Carcinoembryonic Antigen / genetics
  • Carcinoembryonic Antigen / immunology*
  • Colonic Neoplasms / genetics
  • Colonic Neoplasms / immunology
  • Colonic Neoplasms / pathology
  • Colonic Neoplasms / radiotherapy
  • Colonic Neoplasms / therapy*
  • Fowlpox virus / genetics*
  • Genetic Vectors*
  • Humans
  • Liver Neoplasms / genetics
  • Liver Neoplasms / immunology
  • Liver Neoplasms / radiotherapy
  • Liver Neoplasms / secondary
  • Liver Neoplasms / therapy*
  • Male
  • Middle Aged
  • National Cancer Institute (U.S.)
  • Pilot Projects
  • Radiation Dosage
  • Radiotherapy, Adjuvant
  • Radiotherapy, Conformal* / adverse effects
  • Rectal Neoplasms / genetics
  • Rectal Neoplasms / immunology
  • Rectal Neoplasms / pathology
  • Rectal Neoplasms / radiotherapy
  • Rectal Neoplasms / therapy*
  • Time Factors
  • Treatment Outcome
  • United States
  • Vaccines, Synthetic / therapeutic use


  • Cancer Vaccines
  • Carcinoembryonic Antigen
  • Vaccines, Synthetic