EUCTR2008-001973-14-NL进行中（未招募）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
Radboud University Nijmegen Medical Centre0 个研究点开始时间: 2008年10月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
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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