NL-OMON37090已完成不适用
TLR ligand matured dendritic cell vaccination in melanoma patients: the key towards a more potent immune induction? - TLR-ligand matured DC vaccinations in melanoma patients
niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
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
- •For both stage III and IV melanoma;- histologically documented evidence of melanoma;- stage III or IV melanoma according to the 2001 AJCC criteria;- HLA-A2.1 phenotype is required;- melanoma expressing gp100 (compulsory) and tyrosinase (non-compulsory);- WHO performance status 0-1 (Karnofsky 100-70%);- life expectancy >3 months;- age 18-70 years;- no clinical signs or symptoms of CNS metastases;- WBC >3.0×109/l, lymphocytes >0.8×109/l, platelets >100×109/l, ;serum crea-tinine <150 µmol/l, serum bilirubin <25 µmol/l;- normal serum LDH (<=450 U/l);- expected adequacy of follow-up;- no pregnant or lactating women;- written informed consent;For stage III melanoma;- interval since regional lymph node dissection is <2 months, or radical lymph node ;dissection is planned;For stage IV melanoma;- at least one unidimensional measurable target lesions according to RECIST, not previously irradiated, and limited tumor burden, according to the responsible physician
排除标准
- •- prior chemotherapy, immunotherapy or radiotherapy <4 weeks prior to planned ;vaccination or presence of treatment-related toxicity;- history of any second malignancy in the previous 5 years, with the exception of adequately treated basal cell carcinoma or carcinoma in situ of the cervix ;serious active infections, HbsAg or HIV positive or autoimmune diseases or organ allografts ;- concomitant use of immunosuppressive drugs;- known allergy to shell fish (since it contains KLH);- rapidly progressive disease;- any serious clinical condition that may interfere with the safe administration of DC
研究者
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