Gemcitabine With Antiangiogenic Peptide Vaccine Therapy in Patients With Pancreatic Cancer

This study has been completed.
Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by:
Wakayama Medical University Identifier:
First received: February 13, 2008
Last updated: February 17, 2009
Last verified: February 2009
The purpose of this study is to evaluate the safety, tolerability and immune response of different doses of VEGFR2-169 emulsified with Montanide ISA 51 in combination with gemcitabine and to determine the recommended phase II dose.

Condition Intervention Phase
Pancreatic Cancer
Biological: VEGFR2-169 and 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 I Study of Gemcitabine With Antiangiogenic Vaccine Therapy Using Epitope Peptide Restricted to HLA-A*2402 Derived From VEGFR2 in Patients With Unresectable, Locally Advanced, Recurrent or Metastatic Pancreatic Cancer

Resource links provided by NLM:

Further study details as provided by Wakayama Medical University:

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

Secondary Outcome Measures:
  • VEGFR2 peptide specific CTL induction in vitro [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • DTH to VEGFR2 peptide [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Changes in levels of regulatory T cells [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Objective response rate as assessed by RECIST criteria [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: 1 years ] [ Designated as safety issue: No ]
  • survival [ Time Frame: 1 years ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: November 2006
Study Completion Date: February 2009
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phase I study Biological: VEGFR2-169 and gemcitabine
Escalating doses of VEGFR2-169 will be administered by subcutaneous injection on days 1,8,15 and 22 of each 28-day treatment cycles(doses of 0.5,1.0,2.0mg/body are planned). Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on days 1,8 and 15. Repeated cycles of VEGFR2-169 and gemcitabine will be administered until patients develop progressive disease or unacceptable toxicity,or for maximum 2 cycles, whichever occurs first.

Detailed Description:
Vascular endothelial growth factor receptor 2(VEGFR2) is essential target for tumor angiogenesis, and VEGFR2-169 induces specific Cytotoxic T lymphocytes (CTL) against VEGFR2 expressed targets. VEGFR2-169 shows strong anti-tumor effects restricted to HLA-A*2402 in vitro, and this peptide induces CTL from cancer patients. 60% in Japanese population have HLA-A*2402. VEGFR2-169 is suitable for clinical trial, and gemcitabine has been approved against pancreatic cancer. Gemcitabine is reported to improve immune-response, therefore synergistic effect between vaccine therapy and chemotherapy will be expected. In this clinical trial, we evaluate the safety, tolerability and immune response of different doses of VEGFR2-169 emulsified with Montanide ISA 51 in combination with gemcitabine and to determine the recommended phase II dose of peptide.

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:


  1. locally advanced or metastatic pancreatic cancer precluding curative surgical resection and recurrent pancreatic cancer
  2. measurable disease by CT scan


  1. ECOG performance status 0-2
  2. Life expectancy > 3 months
  3. Laboratory values as follows

    • 2000/mm3 < WBC < 15000/mm3
    • Platelet count > 75000/mm3
    • Bilirubin < 3.0 mg/dl
    • Aspartate transaminase < 150 IU/L
    • Alanine transaminase < 150 IU/L
    • Creatinine < 3.0 mg/dl
  4. HLA-A*2402
  5. Able and willing to give valid written informed consent

Exclusion Criteria:

  1. Pregnancy(woman of childbearing potential:Refusal or inability to use effective means of contraception)
  2. Breastfeeding
  3. Active or uncontrolled infection
  4. Concurrent treatment with steroids or immunosuppressing agent
  5. Prior chemotherapy of gemcitabine
  6. Prior chemotherapy,radiation therapy, or immunotherapy within 4 weeks
  7. Serious or nonhealing wound, ulcer, or bone fracture
  8. Active or uncontrolled other malignancy
  9. Ileus
  10. Interstitial pneumonia
  11. Decision of unsuitableness by principal investigator or physician-in-charge
  Contacts and Locations
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Please refer to this study by its identifier: NCT00622622

Wakayama Medical University Hospital
811-1 Kimiidera, Wakayama, Wakayama, Japan
Sponsors and Collaborators
Wakayama Medical University
Human Genome Center, Institute of Medical Science, University of Tokyo
Study Chair: Hiroki Yamaue, MD Wakayama Medical University, Second Department of Surgery
  More Information


Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Second Department of Surgery, Wakayama Medical University Identifier: NCT00622622     History of Changes
Other Study ID Numbers: WPR2-0710 
Study First Received: February 13, 2008
Last Updated: February 17, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms by Site
Pancreatic Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Infective Agents
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses processed this record on May 01, 2016