Gemcitabine With Peptide Vaccine Therapy in Treating Patients With Bile Duct Cancer

Brief Title

Gemcitabine With Peptide Vaccine Therapy in Treating Patients With Bile Duct Cancer

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 Description

      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.
    

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

Safety (toxicities as assessed by NCI CTCAE version 3)

Secondary Outcome

 URLC10 peptide specific CTL induction

Condition

Bile Duct Cancer

Intervention

Peptide vaccine for URLC10

Study Arms / Comparison Groups

 Phase I study

Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Biological

Estimated Enrollment

9

Start Date

February 2008

Completion Date

December 2016

Primary Completion Date

April 2016

Eligibility Criteria

        Inclusion Criteria:

        DISEASE CHARACTERISTICS

          1. Advanced bile duct cancer precluding curative surgical resection and recurrent bile
             duct cancer

          2. measurable disease by CT scan, ultrasonography, or other imaging modalities.

        PATIENTS CHARACTERISTICS

          1. ECOG performance status 0-2

          2. Life expectancy >3 months

          3. Laboratory values as follows 2,000/mm³< WBC < 15,000/mm³ Platelet count ≥ 75,000/mm³
             Bilirubin ≤ 1.5 x the institutional normal upper limits AST, ALT, ALP ≤ 2.5 x the
             institutional normal upper limits Creatinine ≤ 1.5 x the institutional normal upper
             limits

          4. HLA-A*2402 or HLA-A*0201

          5. Able and willing to give valid written informed consent

        Exclusion Criteria:

          1. Pregnancy (women of childbearing potential: Refusal or inability to use effective
             means of contraception)

          2. Breastfeeding

          3. Serious or uncontrolled infection

          4. Prior chemotherapy (except gemcitabine), radiation therapy, or immunotherapy within 4
             weeks.

          5. Other malignancy within 5 years prior to entry into the study

          6. Concomitant treatment with steroids or immunosuppressing agent

          7. Disease to the central nervous system

          8. Decision of unsuitableness by principal investigator or physician-in-charge
      

Gender

All

Ages

20 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Yuzo Yamamoto, MD, , 

Location Countries

Japan

Location Countries

Japan

NCT ID

NCT00624182

Organization ID

AUGIS-001

Responsible Party

Principal Investigator

Study Sponsor

Akita University Hospital

Collaborators

 Human Genome Center, Institute of Medical Science, University of Tokyo

Study Sponsor

Yuzo Yamamoto, MD, Study Chair, Department of Gastroenterological Surgery, Akita University, School of Medicine

Verification Date

June 2015