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

NCT ID: NCT00678509

Last Updated: 2009-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-03-31

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Keywords

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HLA-A*2402 Peptide Vaccine TTK

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

TTK peptide mixed with Montanide ISA 51

Intervention Type BIOLOGICAL

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.

Interventions

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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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Human Genome Center, Institute of Medical Science, University of Tokyo

OTHER

Sponsor Role collaborator

Tokyo University

OTHER

Sponsor Role lead

Responsible Party

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The Institute of Medical Science, the University of Tokyo

Principal Investigators

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Masaru Shinozaki, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

Head, Department of Surgery

Locations

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The Institute of Medical Science, the University of Tokyo

Minato-ku, Tokyo, Japan

Site Status

Countries

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Japan

Related Links

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http://www.transrec.jp/

Research Hospital, the Institute of Medical Science, the University of Tokyo

Other Identifiers

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Breast-A24-I, II

Identifier Type: -

Identifier Source: org_study_id