NCT00400322已完成不适用
A Randomized Double Blind Controlled Proof of Concept Study of the Efficacy and Safety of Valcyte® as an add-on Therapy in Patients With Malignant Glioblastoma With Successful Surgical Resection of at Least 90 % of the Initial Tumor and CMV Infection Demonstrated Histologically and Immunohistochemically.
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 3
- 主要终点
- Tumor size
研究概览
简要总结
The purpose of this study is to investigate if treatment of CMV infection by antiviral drug Valcyte (R) affects the clinical outcome of glioblastoma multiforme in patients with local CMV infection in tumor tissue. The investigators' hypothesis states that CMV infection promotes tumor development and disease progression and inhibits immune responses against the tumor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
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
- •Glioblastoma grade IV
- •Cytomegalovirus detected in tumor
- •At least 90% resection of tumor
排除标准
- •Decreased kidney function
- •Pregnancy
- •Neutropenia
- •Thrombocytopenia
- •Patient not tolerating the drug
研究组 & 干预措施
Valganciclovir
Active Comparator
干预措施: Valganciclovir (Valcyte) (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Tumor size
时间窗: Week twenty four
次要结局
- Disease status(24 months)
- Patient survival(24 months)
研究者
Cecilia Soderberg-Naucler
Professor
Karolinska Institutet
研究点 (3)
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