Clinical Trial: Gemcitabine With Peptide Vaccine Therapy in Treating Patients With Bile Duct Cancer

Study Status: Suspended
Recruit Status: Suspended
Study Type: Interventional

Official Title: Phase 1 Study of Gemcitabine With Vaccine Therapy Targeting Tumor Antigen, URLC10, For The Patients With Unresectable or Recurrent Bile Duct Cancer

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Akita University Hospital

Current Primary Outcome: Safety (toxicities as assessed by NCI CTCAE version 3) [ Time Frame: 5 years ]

Original Primary Outcome: Safety (toxicities as assessed by NCI CTCAE version 3) [ Time Frame: 1 year ]

Current Secondary Outcome:

  • URLC10 peptide specific CTL induction [ Time Frame: 5 years ]
  • DTH to URLC10 peptide [ Time Frame: 5 years ]
  • Changes in levels of regulatory T cells [ Time Frame: 5 years ]
  • Objective response rate as assessed by RECIST criteria [ Time Frame: 5 years ]
  • Time to progression [ Time Frame: 5 years ]
  • Survival rate [ Time Frame: 5 years ]


Original Secondary Outcome:

  • URLC10 peptide specific CTL induction in vitro [ Time Frame: 1 year ]
  • DTH to URLC10 peptide [ Time Frame: 1 year ]
  • Changes in levels of regulatory T cells [ Time Frame: 1 year ]
  • Objective response rate as assessed by RECIST criteria [ Time Frame: 1 year ]
  • Time to progression [ Time Frame: 1 year ]
  • Survival rate [ Time Frame: 1 year ]


Information By: Akita University Hospital

Dates:
Date Received: February 19, 2008
Date Started: February 2008
Date Completion: December 2016
Last Updated: June 22, 2015
Last Verified: June 2015