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 Information
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
Administrative Informations
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