Tumor Vaccine Therapy Against Advanced Esophageal Cancer Using HLA-A*2402 Restricted Epitope Peptides Drived From URLC10
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Safety(Phase I:toxicities as assessed by NCI CTCAE version3)
研究概览
简要总结
The purpose of this study it to evaluate the safety and immune response of peptides (URLC10) emulsified with Montanide ISA51 in treating patients with unresectable, advanced or recurrent esophageal cancer.
详细描述
URLC10 have been identified as cancer specific molecules especially in non small cell lung cancer using genome-wide expression profile analysis by cDNA microarray technique. In a prior study, it has been shown that URLC10 are upregulated in human esophageal tumors. The investigators identified that peptides derived from these proteins significantly induce the effective tumor specific CTL response in vitro. According to these findings, in this trial, we evaluate the safety, immunological and clinical response of URLC10 peptide. Patients will be vaccinated once in one week to the eighth vaccine and will be vaccinated once in two weeks from the ninth vaccine. On each vaccination day, the URLC10 peptide (1mg) mixed with Montanide ISA 51 will be administered by endodermic injection
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have Advanced or recurrent esophageal cancer, and treatment has failed, or in the situation where effective therapy is not available, or has been refused due to severe adverse effects of chemotherapy
- •WHO performance status of 0 to 2
- •Age ≥ 20 years, ≤80 years
- •The patient does not need to have a measurable disease, but must have a disease that an effect judgment is possible
- •Passing from previous treatment more than two weeks. Passing from radiation therapy more than four weeks.
- •Expected survival of at least 3 months
- •WBC≥ 1,500/mm³ WBC≤ 15,000/mm³ Platelet count ≥ 50,000/mm³ Total bilirubin ≤ 3 x the institutional normal upper limits AST, ALT ≤ 3 x the institutional normal upper limits Creatinine ≤ 3 x the institutional normal upper limits
- •Patients must be HLA-A2402
- •Able and willing to give valid written informed consent
排除标准
- •Pregnancy, Promise of the pregnancy, Hope of the pregnancy, Breastfeeding
- •Serious infections requiring antibiotics
- •Concurrent treatment with steroids or immunosuppressing agent
- •Disease to the central nervous system
- •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)
时间窗: 28 days after beginning protocol
次要结局
- efficacy(Feasibility as evaluated by RECIST)(28 days after beginning protocol)
- evaluate immunological responses(28 days after beginning protocol)
研究者
Hajime Ishikawa
department of surgery
Kinki University