Phase I Study of Peptide Vaccine and S-1 Plus CPT-11 Chemotherapy in Patients With Unresectable Recurrent or Metastatic Colorectal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Safety (toxicities as assessed by NCI CTCAE version 3)
研究概览
简要总结
The purpose of this study is to evaluate the safety and immune response of different doses of RNF43-721 emulsified with Montanide ISA 51 in combination with S-1/CPT-11 chemotherapy.
详细描述
RNF43 is a cancer testis antigen which express widely in colorectal cancer tissue but not in normal organs. RNF43-721 induces HLA A24 restricted specific cytotoxic T lymphocytes (CTL) against RNF43 expressed target. S-1/CPT-11 chemotherapy is performed unresectable advanced colorectal cancer in Japan and is reported to be obtained almost the same result compared with FOLFOX or FOLFIRI as first-line chemotherapy for advanced colorectal cancer. Because synergistic effect between vaccine therapy and chemotherapy will be expected, we plan phase I study to evaluate the safety and immune response of different doses of RNF43-721 emulsified with Montanide ISA 51 in combination with S-1/CPT-11 chemotherapy.
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
- •ECOG performance status 0-1
- •Life expectancy > 3 months
- •HLA A24 positive
- •Histologically diagnosed as colorectal cancer with measurable lesion
- •Laboratory values as follows:WBC>3000/mm3, Hb>10mg/dl, Plt>75000/mm3, Creatinine<1.2mg/dl, T. bil.<1.5mg/dl, AST, ALT<3x normal limits
- •Able and willing to give valid written informed consent
排除标准
- •Active other malignancy
- •Active infection
- •Immune deficiency
- •Current treatment with steroids and immunosuppressive agents
- •Pregnancy and breast feeding
- •Inability oral intake
- •Psychic disease
- •Hepatitis B, C virus
- •HIV infection
结局指标
主要结局
Safety (toxicities as assessed by NCI CTCAE version 3)
时间窗: 2 months
次要结局
- Specific CTL induction in vitro, Objective rate as assessed by RECST criteria(2 months)
研究者
Kazuhiko Yoshimatsu
Ascociate professor of surgery
Tokyo Women's Medical University