LUD 00-009: phase 1 study of intensive course immunization with NY-ESO-1 peptides in HLA-A2 positive patients with NY-ESO-1-expressing cancer

Cancer Immun. 2007 Oct 19;7:16.


NY-ESO-1 is a cancer-testis antigen and an attractive target for immunotherapy in patients with different malignancies. Here we report the results of a phase I clinical study of intensive course NY-ESO-1 peptide vaccination, evaluating the safety, immunogenicity and clinical response in HLA-A2 positive patients with NY-ESO-1 expressing cancers. Of 20 patients enrolled in the trial, 14 completed at least 2 cycles of immunization and were evaluable for clinical and immunological response. Five of these evaluable patients were treated in cohort 1 (baseline seropositive) and 9 patients were treated in cohort 2 (baseline seronegative). During vaccination, NY-ESO-1-specific CD8+ T-cells were induced in 3 of 9 baseline seronegative patients. In patients with pre-existing antigen-specific CD8+ T-cells, their number increased or remained stable. In contrast to previous immunization protocols with less intensive immunization schedules, we observed a rapid induction of high magnitude NY-ESO-1 peptide-specific T-cell responses detectable already on day 15-22 of immunization. A specific immune response of high magnitude and early onset may be more effective in eliminating minimal residual disease in adjuvant treatment situations and in preventing tumor progression due to immune escape mechanisms.

Publication types

  • Clinical Trial, Phase I
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Antigens, Neoplasm / immunology*
  • CD8-Positive T-Lymphocytes / immunology
  • Cancer Vaccines / administration & dosage*
  • Cancer Vaccines / immunology
  • Cohort Studies
  • Female
  • Granulocyte-Macrophage Colony-Stimulating Factor / administration & dosage
  • HLA-A2 Antigen / metabolism*
  • Humans
  • Hypersensitivity, Delayed / immunology
  • Immunization
  • Immunotherapy*
  • Lymphatic Metastasis
  • Male
  • Membrane Proteins / immunology*
  • Middle Aged
  • Neoplasm Proteins / immunology*
  • Neoplasms / immunology
  • Neoplasms / therapy*
  • Peptide Fragments / immunology*
  • T-Lymphocytes, Cytotoxic / immunology
  • Treatment Outcome


  • Antigens, Neoplasm
  • CTAG1B protein, human
  • Cancer Vaccines
  • HLA-A2 Antigen
  • Membrane Proteins
  • Neoplasm Proteins
  • Peptide Fragments
  • peptide NY-ESO-1 157-165
  • Granulocyte-Macrophage Colony-Stimulating Factor