Histocompatibility Leukocyte Antigen (HLA)-A*0201 Restricted Peptide Vaccine Therapy in Patients With Breast Cancer

Phase I/II Study of Multiple-Vaccine Therapy Using Epitope Peptide Restricted to HLA-A*0201 in Treating Patients With Refractory Breast Cancer

Status

Terminated

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00677326

Enrollment

Registered

2008-05-14

Start date

2008-05-31

Completion date

2009-05-31

Last updated

2009-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

HLA-A*0201, Peptide Vaccine, VEGFR1, VEGFR2

Brief summary

The purpose of this study is to evaluate the safety and time to progression of HLA-A\*0201 restricted epitope peptides VEGFR1 and VEGFR2 emulsified with Montanide ISA 51 in advanced breast cancer patients.

Detailed description

VEGF receptor 1 and 2 are essential targets to tumor angiogenesis, and we identified that peptides derived from these receptors significantly induce 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 those peptides. Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, VEGFR1 peptide (1mg) and VEGFR2 peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection. Repeated cycles of the 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 these peptide vaccine. In the following phase II study, we evaluate the immunological and clinical response of this vaccine therapy.

Interventions

BIOLOGICALVEGFR1 and VEGFR2

Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, VEGFR1 peptide (1mg) and VEGFR2 peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 85 Years

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\*0201 * 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 * Unhealed external wound * Concurrent treatment with steroids or immunosuppressing agent * Prior chemotherapy,radiation therapy, or immunotherapy within 4 weeks * Uncontrolled brain and/or intraspinal lesion(s) * 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

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026