NCT01032122终止1 期
Efficacy and Safety of Rituximab, an Anti-CD20 (Cluster of Differentiation Antigen 20) Therapeutic Agent, in Metastatic Melanoma: a Pilot Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- disease-free interval
研究概览
简要总结
The purpose of this study is to determine whether rituximab as an adjuvant therapy in clinical stage IIIc / IV (no evidence of disease, AJCC (American Joint Committee on Cancer) 2002) melanoma patients is safe and prolongs overall survival and disease-free interval.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Histologically verified non-ocular melanoma stage IIIc/IV, no evidence of disease
排除标准
- •ECOG (Eastern Cooperative Oncology Group) performance status > 2
- •Ocular melanoma
- •Immunodeficiency syndromes or hypogammaglobulinaemia
- •Active autoimmune diseases
- •Treatment with immunosuppressive agents other than steroids
- •Depressed bone marrow function (Leukopenia <3000, platelet count <100.000)
- •Cardiac insufficiency NYHA (New York Heart Association) IV
- •active Hepatitis B,C, or HIV infection
- •Pregnancy or lactation
- •Interstitial pulmonary disease
- •Former treatment with anti-CD20 antibody
研究组 & 干预措施
rituximab
Experimental
干预措施: rituximab (Drug)
结局指标
主要结局
disease-free interval
时间窗: 42 months
次要结局
- overall survival(42 months)
研究者
Stephan N. Wagner, MD
MD
Medical University of Vienna
研究点 (1)
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