Bile Duct Cancer Clinical Trial
Official title:
Phase 1 Study of Gemcitabine With Vaccine Therapy Targeting Tumor Antigen, URLC10, For The Patients With Unresectable or Recurrent Bile Duct Cancer
The purpose of this study is to evaluate the safety, tolerability, and immune response of different doses of URLC10 peptide emulsified with Montanide ISA51 in combination with gemcitabine. Recommended phase II dose will be also determined.
Our previous studies have demonstrated that up-regulated lung cancer 10 (URLC10) has been
identified as a new target of tumor associated antigen using cDNA microarray technique
combined with the expression profiles of normal and cancer tissues. We have also found that
100% of tissue samples from bile duct cancer express URLC10. We have determined the
HLA-A*2402 and HLA-A*0201 restricted epitope peptides derived from URLC10.These epitope
peptides have shown to induce specific Cytotoxic T Lymphocytes (CTL). Furthermore, 60% and
20% of Japanese population have HLA-A*2402 and HLA-A*0201, respectively. Therefore, these
peptides are suitable for clinical trial. On the other hand, gemcitabine is a drug approved
against bile duct cancer. Recent studies has reported that gemcitabine has an additional
ability to improve immune response. From these results, synergistic effect between vaccine
therapy and chemotherapy using gemcitabine will be expected.
In this clinical trial, we evaluate the safety, tolerability, and immune responses of
different doses of URLC10 peptide emulsified with Montanide ISA51 as immunochemotherapy in
the patients with unresectable or recurrent bile duct cancer. Toxicity profiles will be
monitored, and antigen specific T cell responses will be described.
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