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

This study has been terminated.
(Difficulty in recruiting)
Sponsor:
Collaborator:
Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by:
Tokyo University
ClinicalTrials.gov Identifier:
NCT00677326
First received: May 12, 2008
Last updated: December 28, 2009
Last verified: May 2009
  Purpose

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 advanced breast cancer patients.


Condition Intervention Phase
Breast Cancer
Biological: VEGFR1 and VEGFR2
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
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 Treating Patients With Refractory Breast 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate immunological responses [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: May 2008
Study Completion Date: May 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Peptide administered
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.

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, immunological and clinical 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. Repeated cycles of the vaccine 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.

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Advanced or recurrent breast cancer
  • Resistant against anthracycline-based and taxane-based chemotherapy or difficult to continue the chemotherapy due to intolerable side effect(s)
  • Resistant against trastuzumab or difficult to continue it due to intolerable side effect(s) when her-2 is positive
  • 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 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)
  • Decision of unsuitableness by principal investigator or physician-in-charge
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00677326

Locations
Japan
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
Investigators
Study Chair: Naohide Yamashita, MD/PhD The Institute of Medical Science, The University of Tokyo
  More Information

Additional Information:
Publications:
Responsible Party: Department of Surgery, The Institute of Medical Science, The University of Tokyo
ClinicalTrials.gov Identifier: NCT00677326     History of Changes
Other Study ID Numbers: Breast-A02-I, II
Study First Received: May 12, 2008
Last Updated: December 28, 2009
Health Authority: Japan: Institutional Review Board

Keywords provided by Tokyo University:
HLA-A*0201
Peptide Vaccine
VEGFR1
VEGFR2

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014