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临床试验/NCT00400322
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.

Karolinska Institutet3 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2006年8月最近更新:
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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cecilia Soderberg-Naucler

Professor

Karolinska Institutet

研究点 (3)

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