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

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
TTK peptide mixed with Montanide ISA 51
Sponsored by
Tokyo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring HLA-A*2402, Peptide Vaccine, TTK

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Institute of Medical Science, the University of Tokyo

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

Outcomes

Primary Outcome Measures

safety (Phase I: toxicities as assessed by NCI CTCAE version3) and efficacy (Phase II: feasibility as evaluated by RECIST)

Secondary Outcome Measures

to evaluate immunological responses

Full Information

First Posted
May 12, 2008
Last Updated
December 28, 2009
Sponsor
Tokyo University
Collaborators
Human Genome Center, Institute of Medical Science, University of Tokyo
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1. Study Identification

Unique Protocol Identification Number
NCT00678509
Brief Title
Histocompatibility Leukocyte Antigen (HLA)-A*2402 Restricted Peptide Vaccine Therapy in Patients With Breast Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Terminated
Why Stopped
Lack of financial support
Study Start Date
May 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Tokyo University
Collaborators
Human Genome Center, Institute of Medical Science, University of Tokyo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
HLA-A*2402, Peptide Vaccine, TTK

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
TTK peptide mixed with Montanide ISA 51
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
to evaluate immunological responses
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masaru Shinozaki, MD/PhD
Organizational Affiliation
Head, Department of Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Institute of Medical Science, the University of Tokyo
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
108-8639
Country
Japan

12. IPD Sharing Statement

Links:
URL
http://www.transrec.jp/
Description
Research Hospital, the Institute of Medical Science, the University of Tokyo

Learn more about this trial

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

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