Phase 1 Study of Multiple Peptide Vaccine Therapy and GM-CSF in Treating Patients With Esophageal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Toxicity of multiple peptide vaccinations
研究概览
简要总结
This is a phase 1 study of multiple peptide vaccine therapy and GM-CSF in treating patients with esophageal cancer.
详细描述
LY6K (lymphocyte antigen 6 complex, locus K) was identified as a new target of tumor associated antigen using cDNA microarray technologies combined with the expression profiles of normal and cancer tissues. On the other hand, anti-angiogenic therapy is now considered to be one of promising approaches to treat of cancer. In this clinical trial, we evaluate the safety and immune responses of multiple peptide cocktail including LY6K and vascular endothelial growth factor receptor 1 (VEGFR1) and vascular endothelial growth factor receptor 2 (VEGFR2) together with IFA and GM-CSF as immunoadjuvants in patients who had LY6K expressed primary esophageal cancer. Toxicity profiles will be monitored, and antigen specific T cell responses will be described.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have metastatic disease of 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, ≤75 years
- •Chemotherapy, any type of radiation therapy, or immunotherapy within 4 weeks before study entry
- •Expected survival of at least 3 months
- •WBC≥ 2,000/mm³ Platelet count ≥ 100,000/mm³ Total bilirubin ≤ 1.5 x the institutional normal upper limits AST, ALT, ALP ≤ 2.5 x the institutional normal upper limits Creatinine ≤ 1.5 x the institutional normal upper limits
- •Patients must be HLA-A2402
- •Primary lesion of esophageal cancer must express LY6K
- •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
- •Serious infections requiring antibiotics
- •Patient with peptic ulcer disease
- •Previous history of intestinal perforation
- •bleeding disorders (INR ≥ 1.5)
- •Necessity of drug-mediated inhibition with platelet function
- •Taking antithrombogenic agents within 10 days
- •Serious hypertension
- •Previous history of arterial thrombosis or venous thrombosis
- •Other malignancy within 5 years prior to entry into the study, except for treated non-melanoma skin cancer and cervical carcinoma in situ
- •Clinically significant heart disease or previous history of myocardial infarction within the past 12 months
- •Concomitant 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
Toxicity of multiple peptide vaccinations
时间窗: one year
次要结局
- Immune responses including LY6K, VEGFR1 and VEGFR2 specific T cells(one year)