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

Tokyo University

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Breast Cancer

Treatments: Biological: TTK peptide mixed with Montanide ISA 51

Study type: Interventional

Funder types: Other

Identifiers

NCT00678509

Breast-A24-I, II

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 estimated patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

A

Experimental group

Treatment:

Biological: TTK peptide mixed with Montanide ISA 51