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

This study has suspended participant recruitment.
Sponsor:
Collaborator:
Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by (Responsible Party):
Hiroshi Uchinami, Akita University Hospital
ClinicalTrials.gov Identifier:
NCT00624182
First received: February 19, 2008
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Bile Duct Cancer
Biological: Peptide vaccine for URLC10
Drug: Gemcitabine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Study of Gemcitabine With Vaccine Therapy Targeting Tumor Antigen, URLC10, For The Patients With Unresectable or Recurrent Bile Duct Cancer

Resource links provided by NLM:


Further study details as provided by Akita University Hospital:

Primary Outcome Measures:
  • Safety (toxicities as assessed by NCI CTCAE version 3) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • URLC10 peptide specific CTL induction [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • DTH to URLC10 peptide [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Changes in levels of regulatory T cells [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Objective response rate as assessed by RECIST criteria [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Survival rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 9
Study Start Date: February 2008
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phase I study Biological: Peptide vaccine for URLC10
Increasing the doses of URLC10 peptides will be administered by subcutaneous injection on day 1, 8, 15, and 22 of each 28-day treatment cycles. Doses of 0.5, 1.0, 2.0mg/body are planned. Repeated cycles of this therapy will be continued until patients develop progressive disease or unacceptable toxicity, or maximum 2 cycles, whichever occurs first.
Other Name: Gemcitabine
Drug: Gemcitabine
Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on day 1, 8, and 15. Repeated cycles of this therapy will be continued until patients develop progressive disease or unacceptable toxicity, or maximum 2 cycles, whichever occurs first.
Other Name: Gemcitabine

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00624182

Locations
Japan
Akita University Hosipital
Akita, Japan, 010-8543
Sponsors and Collaborators
Akita University Hospital
Human Genome Center, Institute of Medical Science, University of Tokyo
Investigators
Study Chair: Yuzo Yamamoto, MD Department of Gastroenterological Surgery, Akita University, School of Medicine
  More Information

Publications:

Responsible Party: Hiroshi Uchinami, Gastroenterological Surgery, Akita University Hospital
ClinicalTrials.gov Identifier: NCT00624182     History of Changes
Other Study ID Numbers: AUGIS-001
Study First Received: February 19, 2008
Last Updated: December 9, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Bile Duct Neoplasms
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on July 24, 2014