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Antiangiogenic Peptide Vaccine Therapy With Gemcitabine in Treating Patient With Pancreatic Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2013 by Takashi Kimura, Fukushima Medical University.
Recruitment status was:  Active, not recruiting
Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by (Responsible Party):
Takashi Kimura, Fukushima Medical University Identifier:
First received: March 7, 2008
Last updated: March 13, 2013
Last verified: March 2013
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 Intervention Phase
Pancreatic Cancer Biological: VEGFR1-1084, VEGFR2-169, and gemcitabine Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I 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

Resource links provided by NLM:

Further study details as provided by Takashi Kimura, Fukushima Medical University:

Primary Outcome Measures:
  • Adverse effect, toxicities as assessed by NCI CTCAE version3.0 [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • feasibility [ Time Frame: 2 years ]

Enrollment: 5
Study Start Date: March 2007
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phase I study Biological: VEGFR1-1084, VEGFR2-169, and gemcitabine
One mg of each peptide will be administered by subcutaneous injection on days 1, 8, 15, and 22 of each 28-day treatment cycles. Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on day 1, 8 and 15.

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

Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
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 PATIENTS CHARACTERISTICS

  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 aggravated wound
  6. Active or uncontrolled other malignancy
  7. Steroids or immunosuppressing agent dependant status
  8. Interstitial pneumonia
  9. Ileus
  10. 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: NCT00639925

Fukushima Medical University Hospital
Fukushima, Japan
Sponsors and Collaborators
Fukushima Medical University
Human Genome Center, Institute of Medical Science, University of Tokyo
Study Chair: Mitsukazu Gotoh, MD, PhD Fukushima Medical University, First depertment of Surgery
  More Information

Responsible Party: Takashi Kimura, Assistant professor, Fukushima Medical University Identifier: NCT00639925     History of Changes
Other Study ID Numbers: FPCR1R2-1
Study First Received: March 7, 2008
Last Updated: March 13, 2013

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Angiogenesis Inhibitors
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors processed this record on September 21, 2017