Phase I/II Study of Multiple-Vaccine Therapy Using Epitope Peptide Restricted to HLA-A*0201 in Treating Patients With Refractory Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- safety(Phase I:toxicities as assessed by NCI CTCAE version3) and efficacy(Phase II:Feasibility as evaluated by RECIST)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •* 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\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
排除标准
- •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
结局指标
主要结局
safety(Phase I:toxicities as assessed by NCI CTCAE version3) and efficacy(Phase II:Feasibility as evaluated by RECIST)
时间窗: 2 months
次要结局
- To evaluate immunological responses(2 months)