Plasmacytoid Dendritic Cells in Vaccination of Stage IV Melanoma Patients: a Phase I Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- intervention-related toxicity
研究概览
简要总结
Dendritic cells (DCs) are the professional antigen-presenting cells of the immune system. As such they are currently used in clinical vaccination protocols in cancer patients, and both immunological and clinical responses have been observed. Several subsets of dendritic cells have been characterized in the peripheral blood. One such subset is referred to as plasmacytoid dendritic cells (PDC), another as myeloid dendritic cells (myDC). To date PDC and myDC have not been evaluated for their capability to induce anti-tumor immune responses in patients. For this reason the investigators will perform a safety and efficacy study with PDC and myDC in stage IV melanoma patients.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stage IV melanoma according to the 2001 AJCC criteria. Limited tumor burden; LDH < 2x upper limit of normal
- •Histological proof of cutaneous melanoma
- •Melanoma expressing tyrosinase and/or gp100 (approximately 20% of cells or more determined by immunohistochemistry staining)
- •HLA Type A2
- •WBC > 3.0 * 10E9/l, lymphocytes > 0.8 * 10E9/l, platelets > 100 * 10E9/l, serum creatinine < 150 umol/l, serum bilirubin < 25 umol/l, normal liver function
- •Expected adequacy of follow up
- •Written informed consent
排除标准
- •autoimmune disorders, concomitant use of immunosuppressive drugs
- •serious concomitant disease, serious active infections, other malignancy in the past 5 years with the exception of curatively treated carcinoma in-situ of the cervix/squamous cell carcinoma of the skin
- •known allergy to shell fish (vaccine contains KLH)
- •pregnancy or lactation
- •clinical signs of CNS metastases, in patients with a clinical suspicion of CNS metastases, a CT scan of the brain should be performed to exclude this
- •prior chemotherapy, immunotherapy, or radiotherapy within three months before planned vaccination is allowed
结局指标
主要结局
intervention-related toxicity
时间窗: Within the first 6 months
all adverse events within a time frame of 3 weeks after the last vaccination will be scored according to Common Terminology Criteria for Adverse Events (CTCAE)Version 4.0
次要结局
- Immunological response(Within the first year)