Phase I Study of Multiple-vaccine Therapy Including Antiangiogenic Vaccine Using Epitope Peptide Restricted to HLA-A*2402 in Treating Patients With Unresectable or Recurrent Non-small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Adverse effects, dose limiting toxicity, and maximum tolerated dose as measured by CTCAE ver3.0 pre treatment, during study treatment, and 3 months after treatment
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, immune response and clinical response of different doses of HLA-A*2402 restricted epitope peptides URLC10, TTK, VEGFR1 and VEGFR2 emulsified with Montanide ISA 51.
详细描述
URLC10 and TTK have been identified as cancer specific molecules especially in non small cell lung cancer using genome-wide expression profile analysis by cDNA microarray technique. We have determined the HLA-A*2402 restricted epitope peptides derived from these molecules. We also tend to use the peptides targeting to tumor angiogenesis. 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.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Disease characteristics
- •Advanced or recurrent non small cell lung cancer
- •Second line or later therapeutic status
- •Patient characteristics
- •ECOG performance status 0-2
- •Life expectancy > 3 months
- •HLA-A*2402
- •Laboratory values as follows 1500/mm3<WBC<15000/mm3 Platelet count>75000/mm3 Bilirubin < 3.0mg/dl Asparate transaminase < 99IU/L Alanine transaminase < 126IU/L Creatinine < 2.2mg/dl
- •Able and willing to give valid written informed consent
排除标准
- •Active and uncontrolled cardiac disease (includes patients with myocardial infarction within 6 months before entry)
- •Pregnancy (woman of child bearing potential)
- •Active and uncontrolled infectious disease
- •Adrenal cortical steroid hormone dependent status
- •Decision of unsuitableness by principal investigator
结局指标
主要结局
Adverse effects, dose limiting toxicity, and maximum tolerated dose as measured by CTCAE ver3.0 pre treatment, during study treatment, and 3 months after treatment
时间窗: 3 months
次要结局
- Peptides specific CTL responses in vitro(3 months)
- Objective response rate as assessed using RECIST criteria(6 months)
- Changes in levels of regulatory T cells(3 months)
研究者
Hiroyuki Suzuki
Professor
Fukushima Medical University