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Antiangiogenic Peptide Vaccine Therapy With Gemcitabine in Treating Patient With Pancreatic Cancer (Phase1/2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00655785
Recruitment Status : Completed
First Posted : April 10, 2008
Last Update Posted : March 14, 2013
Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by (Responsible Party):
Takashi Kimura, Fukushima Medical University

Brief Summary:
The purpose of this study is to evaluate the safety, and tolerability of HLA-A*2402 restricted epitope peptide VEGFR1 and VEGFR2 emulsified with Montanide ISA 51 in combination with gemcitabine

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Biological: VEGFR1-1084, VEGFR2-169 Drug: Gemcitabine Phase 1 Phase 2

Detailed Description:
Vascular endothelial growth factor receptor 1 and 2 (VEGFR1 andVEGFR2) are essential targets to tumor angiogenesis, and we identified that peptides derived from these receptors significantly induce the effective tumor specific CTL response in vitro and in vivo. According to these findings, in this trial, we evaluate the safety, tolerability and immune response of these peptide emulsified with Montanide ISA 51 in combination with gemcitabine

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/Ⅱ Sturdy on Antiangiogenic Vaccine Therapy Using Epitope Peptide Derived From VEGFR1 and VEGFR2 With Gemcitabine in Treating Patients With Unresectable, Recurrent, or Metastatic Pancreatic Cancer
Study Start Date : September 2007
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Phase 1/2 study Biological: VEGFR1-1084, VEGFR2-169
One mg of each peptide will be administered by subcutaneous injection on days 1, 8, 15, and 22 in group A, on days 3, 10, 17, 24 in group B, or 5, 12, 19, 26 in group C

Drug: Gemcitabine
Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on day 3, 10 and 17

Primary Outcome Measures :
  1. toxicities as assessed by NCI-CACAE ver3) [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Differences of peptide specific CTL response in vitro among sequence of gemcitabine and peptide vaccine administration [ Time Frame: 3months ]
  2. CD8 population [ Time Frame: 3months ]
  3. Change in level of regulatory T cells [ Time Frame: 3months ]
  4. Objective response rate [ Time Frame: 1year ]
  5. feasibility [ Time Frame: 1year ]
  6. Survival [ Time Frame: 1year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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:

    • 2,000/mm3 < WBC < 15000/mm3
    • Platelet count ≥ 750,000/mm³
    • Total Bilirubin ≤ 1.5 x
    • 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 (women of childbearing potential: Refusal or inability to use effective means of contraception)
  2. Breast-feeder
  3. Active or uncontrolled infection
  4. Prior chemotherapy, radiation therapy, or immunotherapy within 4 weeks
  5. Serious or uncured wound
  6. Active or uncontrolled other malignancy
  7. Steroids or immunosuppressing agent dependent status
  8. Interstitial pneumonia
  9. Ileus
  10. Decision of unsuitableness by principal investigator or physician-in-charge

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00655785

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Fukushima Medical University Hospital
Fukushima, Japan, 960-1295
Sponsors and Collaborators
Fukushima Medical University
Human Genome Center, Institute of Medical Science, University of Tokyo
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Study Chair: Mitsukazu Gotoh, M.D. & Ph.D Fukushima Medical University, Department
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Responsible Party: Takashi Kimura, Assistant professor, Fukushima Medical University Identifier: NCT00655785    
Other Study ID Numbers: FPCR1R2-2
First Posted: April 10, 2008    Key Record Dates
Last Update Posted: March 14, 2013
Last Verified: March 2013
Keywords provided by Takashi Kimura, Fukushima Medical University:
Epitope peptide
Pancreatic cancer
Vaccination VEGFR1
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs