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Histocompatibility Leukocyte Antigen (HLA)-A*2402 Restricted Peptide Vaccine Therapy in Patients With Breast Cancer

This study has been terminated.
(Lack of financial support)
Sponsor:
Collaborator:
Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by:
Tokyo University
ClinicalTrials.gov Identifier:
NCT00678509
First received: May 12, 2008
Last updated: December 28, 2009
Last verified: March 2009
History of Changes
  Purpose

The purpose of this study is to evaluate the safety and time to progression of HLA-A*2402 restricted epitope peptide TTK emulsified with Montanide ISA 51.


Condition Intervention Phase
Breast Cancer
 Biological: TTK peptide mixed with Montanide ISA 51
 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*2402 in Treating Patients With Refractory Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

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 ]

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: TTK peptide mixed with Montanide ISA 51
Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, TTK peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.

Detailed Description:

TTK has been identified as cancer specific molecules especially in breast cancer using genome-wide expression profile analysis by cDNA microarray technique. We have determined the HLA-A*2402 restricted epitope peptide derived from this molecule and identified that this peptide significantly induces 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 that peptide. Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, TTK-A24-567 peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection. Repeated cycles of 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 this 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*2402

  • 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
  • Concurrent treatment with steroids or immunosuppressing agent
  • Prior chemotherapy,radiation therapy, or immunotherapy within 4 weeks
  • Uncontrolled brain and/or intraspinal
  • Decision of unsuitableness by principal investigator or physician-in-charge
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00678509

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
Principal Investigator: Masaru Shinozaki, MD/PhD Head, Department of Surgery
  More Information

Additional Information:
Research Hospital, the Institute of Medical Science, the University of Tokyo  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Department of Surgery, The Institute of Medical Science, the University of Tokyo
ClinicalTrials.gov Identifier: NCT00678509     History of Changes
Other Study ID Numbers: Breast-A24-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*2402
Peptide Vaccine
TTK

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Freund's Adjuvant
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013