Phase I Study of Chemoradiation Therapy With Epitope Peptide Vaccine Therapy in Treating Patients With Unresectable, Advanced or Recurrent Esophageal Cancer
试验速览
- 阶段
- 1 期
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Safety(toxicities as assessed by NCI CTCAE version3)
研究概览
简要总结
The purpose of this study is to evaluate the safety and immune response of multiple peptides (URLC10, TTK, KOC1 VEGFR1, and VEGFR2) emulsified with Montanide ISA51 in combination with chemotherapy (CDDP, 5-FU) plus radiation therapy in treating patients with unresectable, advanced or recurrent esophageal cancer.
详细描述
Up-regulated ling cancer 10 (URLC10), TTK protein kinase (TTK) and K homology domain containing protein over expressed in cancer (KOC1) were identified as new targets of tumor associated antigens using cDNA microarray technologies combined with the expression profiles of normal and cancer tissues. Furthermore, anti-angiogenic therapy is now considered to be one of promising approaches for treating cancer. Vascular endothelial growth factor receptor 1 (VEGFR1) and vascular endothelial growth factor receptor 2 (VEGFR2) are essential targets for tumor angiogenesis. Epitope peptides for these targets are able to induce cytotoxic T lymphocytes (CTL) restricted to HLA-A *2402 in vivo. On the other hand, chemotherapy (CDDP, 5-FU) plus radiation therapy has been to be a standard treatment for unresectable advanced esophageal cancer. In this clinical trial, we evaluate the safety and immune responses of different doses of multiple peptides (URLC10, TTK, KOC1, VEGFR1, and VEGFR 2) emulsified with Montanide ISA 51 in combination with chemotherapy (CDDP, 5-FU) plus radiation therapy in treating patients with unresectable, advanced or recurrent esophageal cancer.
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 unresectable, locally advanced, recurrent or metastatic disease of esophageal cancer.
- •measurable disease by CT scan
- •ECOG performance status of 0 to 2
- •Expected survival of at lease 3months
- •Patients must be HLA-A2402
- •Laboratory values as follow:
- •WBC > 2000/mm3,
- •Platelet count > 75000/mm3,
- •Total bilirubin < 1.5 x the institutional normal upper limits,
- •Creatinine < 1.5 x the institutional normal upper limits,
- •AST. ALT. ALP < 2.5 x the institutional normal upper limits
- •Able and willing to give valid written informed consent
排除标准
- •Pregnancy (women of childbearing potential:Refusal or inability to use effective means of contraception)
- •Breastfeeding
- •Active or uncontrolled infection
- •Prior chemotherapy,radiation therapy or immunotherapy within 4 weeks
- •Concurrent treatment with steroid or immunosuppressing agent
- •Patient with peptic ulcer disease
- •Active or uncontrolled other malignancy
- •Other malignancy within 5 years prior to entry into the study, expect for treated non-melanoma skin cancer and cervical carcinoma in situ
- •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(toxicities as assessed by NCI CTCAE version3)
时间窗: 3 months
次要结局
- Peptide specific CTL induction(3 months)
- DTH to peptide(3 months)
- Changes in levels of regulatory T cells(3 months)
- Objective response rate as assessed by RECIST criteria(1 year)
- Time to progression(1 year)
- survival(1 year)