NL-OMON35508已完成不适用
Intradermal naked DNA vaccination for mounting tumor-specific immunity in stage IV melanoma patients: a phase I clinical study - DNA vaccination in metastatic melanoma
KI-AV0 个研究点目标入组 15 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
- 15
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
- •Age above 18 years
- •Performance score: WHO 0 or 1
- •Life expectancy of >= 3 months
- •Histologically or cytologically proven metastatic melanoma.
- •Expression of MART-1.
- •HLA-A*0201 positive.
- •Evaluable disease.
- •Disease progression after chemotherapy-based treatment.
- •Adequate bone marrow (WBC > 3.0/nL, platelets > 100/nL), renal function (creatinine clearance > 40 mL/min, and liver function (bilirubin < 1.5 x ULN, normal blood coagulation)
- •Willing and able to undergo the planned study procedures
排除标准
- •Previous MART-1-specific immunotherapy.
- •Patients with severe cardiac, respiratory, or metabolic disease.
- •Symptomatic brain metastases.
- •Use of systemic steroids or other immunosuppressive drugs.
- •Use of oral anticoagulant drugs.
- •Other cancers, except basal cell carcinomas or cervical CIS.
- •Severe infections requiring antibiotics.
- •Lactation or pregnancy
- •Not willing to take adequate contraceptive measures.
研究者
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