NL-OMON33733已完成2 期
mRNA-transfected dendritic cell vaccination in high risk uveal melanoma patients - mRNA-DC vaccination in high risk uveal melanoma
niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 38 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- histologically documented evidence of uveal melanoma
- •- HLA-A02.01 phenotype is required for treatment group
- •- melanoma expressing gp100 (compulsory) and tyrosinase (non-compulsory)
- •- high risk genetic profile (loss of chromosome 3) as determined by FISH
- •- interval since local treatment of uveal melanoma is <12 months
- •- no signs of liver metastasis as determined by diagnostic CT-abdomen
- •- normal serum LDH
- •- no clinical signs of CNS metastases
- •- WHO performance status 0-1 (Karnofsky 100-70%)
- •- life expectancy >3 months
- •- age 18-75 years
- •- expected adequacy of follow-up
- •- no pregnant or lactating women
- •- written informed consent
排除标准
- •- history of second malignancy, adequately treated basal cell carcinoma or
- •carcinoma in situ of the cervix is acceptable
- •- serious active infections, HbsAg or HIV positive (test only in case of high risk or
- •clinical suspicion)
- •- autoimmune diseases or organ allografts
- •- concomitant use of immunosuppressive drugs
- •- known allergy to shell fish (since it contains KLH)
研究者
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