NCT01844661已完成1 期
Phase 1 Trial of Celyvir in Children and Adults With Metastatic and Refractory Solid Tumors.
Hospital Infantil Universitario Niño Jesús, Madrid, Spain2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2013年1月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Adverse effects after intravenous infusions
研究概览
简要总结
The investigators will evaluate the safety of weekly infusions (n=6) of CELYVIR in children and adults with metastatic and refractory solid tumors. CELYVIR consists in bone marrow-derived autologous mesenchymal stem cells (MSCs) infected with ICOVIR5, an oncolytic adenovirus. In addition to data on toxicities the investigators will evaluate clinical response.
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
- 6 Months 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children: Up to 18 yrs. Refractory to at least 2 previous therapy lines. Life expectancy more than 6 months. Measurable disease.
- •Adults: 18-75 yrs. Refractory to at least 2 previous therapy lines. ECOG (Eastern Cooperative Oncology Group) <
- •Measurable disease.
排除标准
- •Pregnancy.
- •Central Nervous System metastasis.
- •Experimental therapy during the previous month.
- •Chemotherapy less than 3 weeks previous.
- •Any organ functionally impaired.
- •Concurrent infectious disease.
结局指标
主要结局
Adverse effects after intravenous infusions
时间窗: 48 hours after each infusion
We will record any sign or symptom that could be related to the infusion of Celyvir.
次要结局
- Clinical outcome(Up to 2 months after the last infusion)
研究者
Manuel Ramírez, MD PhD
Dr.
Hospital Infantil Universitario Niño Jesús, Madrid, Spain
研究点 (2)
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