NCT00204581已完成2 期
Intralesional Treatment With Interleukin-2 (Proleukin) in Soft Tissue Melanoma Metastases. A Phase II, Prospective, Open, Multicenter Trial
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Efficacy in regard to complete and partial response
研究概览
简要总结
The intra-/perilesional application of interleukin-2 seems to be a safe and effective treatment of skin and soft tissue metastases in malignant melanoma. Especially in case of intransit metastases the overall survival rate is still 20-30%.
However, the management of intransit metastases is sometimes difficult because of frequent recurrences. IL-2 intralesionally seems to be an non-invasive option as pilot studies indicate. In this study the safety and efficacy of IL-2 are evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Histologically proven melanoma
- •Have confirmed stage IIIB or stage IV disease (AJCC 2002) with skin or soft-tissue metastases
排除标准
- •Pregnant or lactating women
- •Patients with severe cardiac disease (e.g. NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina)
- •Patients with severe liver disease or severe renal disease
- •Simultaneous immunosuppressive treatment (e.g. steroids)
- •Simultaneous chemotherapy
- •Pretreated soft-tissue or skin metastases (e.g. cryo-, radiotherapy)
结局指标
主要结局
Efficacy in regard to complete and partial response
时间窗: 4 weeks
次要结局
- Overall survival(every 6 months)
- Side-effects(during treament and 4 weeks afterwards)
研究者
研究点 (2)
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