NCT01864759已完成1 期
Phase I Clinical Trial of Endovenous Administration of Conditionally Replicative Adenovirus ICOVIR-5 in Patients With Locally Advanced or Metastatic Melanoma
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Maximum tolerated dose
研究概览
简要总结
The investigators will evaluate the safety of a single endovenous infusion of ICOVIR5 in adults with locally advanced and metastatic melanoma. ICOVIR5 consists in a conditionally replicative or oncolytic adenovirus.
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
- •Malignant melanoma advanced or metastatic.
- •Other than 18 years
- •Karnofsky index > 60 %
- •Life expectancy > 3 months
- •ALT/AST <=2.5 times the upper normal limit
- •Creatinine clearance >= 50 ml/min.
- •Bilirubin <25 umol/l
- •Alkaline phosphatase <= 2.5 time upper normal limit
- •Normal bone marrow function: Neutrophils >=1.5 E9/L, platelets >= 1E11/L, hemoglobin >= 100 g/l, Normal prothrombin time and thromboplastin time,
- •HIV negative
- •Measurable disease
- •Signed informed consent.
排除标准
- •Geographical, social or psychological conditions that may impair the protocol compliance.
- •Active infections or other severe medical status.
- •History of liver disease.
- •Other or concomitant treatments for melanoma or investigational product.
- •Previous participation in studies with adenovirus.
- •Virus diseases diagnosed two weeks before inclusion.
- •Immunosuppressive concomitant treatments
- •Concomitant malignant haematological disease.
- •Patients having family members with immunodeficient status or disease
- •Patients with Li Fraumeni syndrome or germinal retinoblastoma gene defects.
研究组 & 干预措施
ICOVIR5
Experimental
ICOVIR-5 oncolytic adenovirus, single administration, endovenous, dose escalation from 1E11 vp to 1E13 vp.
干预措施: ICOVIR-5 (Biological)
结局指标
主要结局
Maximum tolerated dose
时间窗: 4 weeks
The highest dose where less than two out of three or six patients suffered dose limiting toxicity.
次要结局
- Recommended dose(4 weeks)
- Anti-tumour activity(4 weeks)
研究者
研究点 (2)
Loading locations...
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