Phase I Study of Peptide Vaccination Therapy Using Novel Cancer Testis Antigens for Locally Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma
We recently identified three HLA-A2402-restricted epitope peptides (TTK protein kinase
(TTK), lymphocyte antigen 6 complex locus K (LY6K), and insulin-like growth factor (IGF)-II
mRNA binding protein 3 (IMP-3)) derived from novel Cancer-Testis antigens (CTA) for the
development of immunotherapies against esophageal squamous cell carcinoma (ESCC), and
reported that the pre-existence of specific T cell responses to these epitope peptides were
frequently seen in ESCC patients. Then, we performed Phase I vaccination trial using
multi-epitopes involving TTK, LY6K, and IMP-3 peptides for locally advanced, recurrent or
metastatic esophageal squamous cell carcinoma who had failed for the standard therapy. Each
of three HLA-A2402-restricted epitope peptides mixed with IFA were injected every week at
five round. Primary endpoints were to evaluate the safety and feasibility of the therapy.
Secondary endpoints were to investigate the immunological monitoring and clinical effect.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety (toxicities as assessed by NCI CTCAE version 3)
3 months
Yes
Koji Kono, MD.PhD
Principal Investigator
First Depatment of Surgery
Japan: Ministry of Health, Labor and Welfare
YMU-01
NCT00682227
August 2006
December 2009
Name | Location |
---|