A phase I study of the optimized cryptic peptide TERT(572y) in patients with advanced malignancies

Oncology. 2006;70(4):306-14. doi: 10.1159/000096252. Epub 2006 Oct 12.


Objective: It was the aim of this study to evaluate the safety of the optimized cryptic peptide TERT(572Y) in pretreated patients with advanced cancer.

Methods: Nineteen patients with progressive and chemotherapy-refractory tumors received escalated doses (2-6 mg) of 2 subcutaneous injections of the optimized TERT(572Y) peptide followed by 4 subcutaneous injections of the native TERT(572) peptide every 3 weeks. Both TERT peptides were coinjected with adjuvant Montanide ISA51. Toxicity was evaluated every 3 weeks and peptide-specific CD8+ cells were detected by flow cytometry using TERT(572Y) tetramers.

Results: Fourteen out of 19 patients completed the vaccination program. No grade III/IV toxicity was observed. Grade I anemia was observed in 4 patients and local skin reaction at the injection site in 11 patients. Other nonhematologic toxicities were mild, and no late toxicity was observed after a median postvaccination follow-up period of 10.7 months. There was no dose-limiting toxicity. Peripheral blood TERT(572Y)-specific CD8+ lymphocytes were detected in 13 out of 14 evaluable patients after 2 injections with the optimized TERT(572Y) peptide. There was no complete or partial response, but 4 patients (21%) with persistent TERT(572Y)-specific CD8+ experienced stable disease for a median of 10.5 months.

Conclusion: TERT(572Y) peptide vaccine is well tolerated and effective in eliciting specific TERT(572Y) CD8+ lymphocytes in pretreated cancer patients, demonstrating that cryptic peptides could be used in cancer immunotherapy.

Publication types

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

MeSH terms

  • Adjuvants, Immunologic / administration & dosage
  • Aged
  • Amino Acid Sequence
  • Autoantigens / immunology
  • CD8-Positive T-Lymphocytes / immunology
  • Cancer Vaccines / therapeutic use*
  • Female
  • Humans
  • Immunotherapy / methods
  • Male
  • Mannitol / administration & dosage
  • Mannitol / analogs & derivatives
  • Maximum Tolerated Dose
  • Middle Aged
  • Molecular Sequence Data
  • Neoplasms / immunology*
  • Neoplasms / therapy*
  • Oleic Acids / administration & dosage
  • Peptides / administration & dosage
  • Peptides / genetics
  • Peptides / immunology
  • Telomerase / administration & dosage*
  • Telomerase / genetics
  • Telomerase / immunology*


  • Adjuvants, Immunologic
  • Autoantigens
  • Cancer Vaccines
  • Oleic Acids
  • Peptides
  • montanide ISA 51
  • Mannitol
  • Telomerase