Breast Cancer
Conditions
Keywords
HLA-A*2402, Peptide Vaccine, TTK
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.
Interventions
BIOLOGICALTTK 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.
Sponsors
Human Genome Center, Institute of Medical Science, University of Tokyo
Tokyo University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety (Phase I: toxicities as assessed by NCI CTCAE version3) and efficacy (Phase II: feasibility as evaluated by RECIST) | 2 months |
Secondary
| Measure | Time frame |
|---|---|
| to evaluate immunological responses | 2 months |
Countries
Japan
Outcome results
None listed