Myeloid and Plasmacytoid Blood Dendritic Cells for Immunotherapy of Stage III Melanoma Patients
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
- immunogenicity - response to KLH
研究概览
简要总结
This is an interventional study to test the immunogenicity of combined adjuvant myDC and pDC vaccination versus adjuvant myDC or pDC vaccination alone in stage III melanoma patients.
详细描述
Stage lll melanoma patients will receive pDC (arm A, n=10), myDC (arm B, n=10) or combined pDC/myDC (arm C, n=10). Subsequent vaccinations will be performed according to the protocol: 2 biweekly vaccinations of intranodal injections with pDC, myDC or the combination with pDC and myDC. After each vaccination the investigators will examine peripheral blood for proliferative and humoral KLH immune responses. After the vaccinations, a DTH with peptide loaded blood DC is performed from which biopsies are taken for T cell analysis. lf patients remain disease free, the investigators will repeat this cycle with a 6 months interval up to a total of three cycles. lf a tumor recurrence occurs a biopsy will be taken for laboratory evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 III melanoma
- •WHO performance status 0-1
- •radical lymph node dissection is schedule or performed within 12 weeks prior to start of study treatment
排除标准
- •irresectable disease
- •any concurrent adjuvant therapy
- •concomitant use of oral immunosuppressive drugs
- •autoimmune diseases
结局指标
主要结局
immunogenicity - response to KLH
时间窗: up to 1.5 years
Proliferative, effector cytokine and humoral responses to keyhole limpet hemocyanin (KLH).The occurrence of the response will be compared between the arms.
immunogenicity - T cells in DTH
时间窗: up to 1.5 years
Functional response and tetramer analysis of DTH infiltrating T cells against tumor peptides. The occurrence of the response will be compared between the arms.
immunogenicity - type I IFN
时间窗: up to 1.5 years
Type I IFN gene expression in PBMC shortly after vaccination. The occurrence of the type I IFN response in patients will be compared between the arms.
次要结局
- biodistribution/localization of pDC and myDC in the lymph node(within 1 week after vaccination 1)
- quality of life(5 years)
- progression-free survival(5 years)
- overall survival(5 years)
- safety - Toxicity will be assessed according to the NCI Common Toxicity Criteria, CTC version 4.0(up to 1.5 years)