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Histocompatibility Leukocyte Antigen (HLA)-A*0201 Restricted Peptide Vaccine Therapy in Patients With Colorectal Cancer

This study has been terminated.
(Lack of financial support)
Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by:
Tokyo University Identifier:
First received: May 12, 2008
Last updated: December 28, 2009
Last verified: January 2009
The purpose of this study is to evaluate the safety and time to progression of HLA-A*0201 restricted epitope peptides VEGFR1 and VEGFR2 emulsified with Montanide ISA 51 in combination with Tegafur/Uracil/Folinate chemotherapy.

Condition Intervention Phase
Colorectal Cancer
Colon Cancer
Rectal Cancer
Biological: VEGFR1 and VEGFR2
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Study of Multiple-Vaccine Therapy Using Epitope Peptide Restricted to HLA-A*0201 in Combination With Tegafur/Uracil/Folinate in Treating Patients With Refractory Colorectal Cancer

Resource links provided by NLM:

Further study details as provided by Tokyo University:

Primary Outcome Measures:
  • safety(Phase I:toxicities as assessed by NCI CTCAE version3) and efficacy(Phase II:Feasibility as evaluated by RECIST) [ Time Frame: 2 months ]

Secondary Outcome Measures:
  • To evaluate immunological responses [ Time Frame: 2 months ]

Estimated Enrollment: 14
Study Start Date: May 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Biological: VEGFR1 and VEGFR2
Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, VEGFR1 peptide (1mg) and VEGFR2 peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection in combination with Tegafur/Uracil/Folinate chemotherapy.
Other Names:
  • UFT
  • UZEL

Detailed Description:
VEGF receptor 1 and 2 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 vivo. According to these findings, in this trial, we evaluate the safety, clinical and immunological response of those peptides. Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, VEGFR1 peptide (1mg) and VEGFR2 peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection. The patients will also receive oral chemotherapy (Tegafur/Uracil/Folinate) simultaneously. Repeated cycles of the vaccine and the chemotherapy will be administered until patients develop progressive disease or unacceptable toxicity, whichever occurs first. In the phase I study, we evaluate the safety and tolerability of these peptide vaccine. In the following phase II study, we evaluate the immunological and clinical response of this vaccine therapy.

Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Advanced or recurrent colorectal cancer
  • Resistant against chemotherapy including CPT-11, l-OHP、+/- 5-FU +/- bevacizumab or difficult to continue the chemotherapy due to intolerable side effect(s)
  • ECOG performance status 0-2
  • Life expectancy > 3 months
  • HLA-A*0201
  • Laboratory values as follows

    • 2000/mm3<WBC<15000/mm3
    • Platelet count>100000/mm3
    • Bilirubin < 3.0mg/dl
    • Asparate transaminase < 150IU/L
    • Alanine transaminase < 150IU/L
    • Creatinine < 3.0mg/dl
  • Able to receive oral Tegafur/Uracil/Folinate therapy
  • Able and willing to give valid written informed consent

Exclusion Criteria:

  • Pregnancy(woman of childbearing potential:Refusal or inability to use effective means of contraception)
  • Breastfeeding
  • Active or uncontrolled infection
  • Unhealed external wound
  • Concurrent treatment with steroids or immunosuppressing agent
  • Prior chemotherapy,radiation therapy, or immunotherapy within 4 weeks
  • Uncontrolled brain and/or intraspinal lesion(s)
  • History of allergy to Tegafur, Uracil, and/or Folinate
  • 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: NCT00677612

The Institute of Medical Science, The University of Tokyo
Minato-ku, Tokyo, Japan, 108-8639
Sponsors and Collaborators
Tokyo University
Human Genome Center, Institute of Medical Science, University of Tokyo
Principal Investigator: Masaru Shinozaki, MD/PhD Head, Department of Surgery
  More Information

Additional Information:
Responsible Party: Department of Surgery, The Institute of Medical Science, The University of Tokyo Identifier: NCT00677612     History of Changes
Other Study ID Numbers: CRC-A02-I, II
Study First Received: May 12, 2008
Last Updated: December 28, 2009

Keywords provided by Tokyo University:
Peptide Vaccine

Additional relevant MeSH terms:
Colorectal Neoplasms
Rectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents processed this record on May 25, 2017