Efficacy and Safety of Valcyte® as an add-on Therapy in Patients With Malignant Glioblastoma and Cytomegalovirus (CMV) Infection
Not Applicable
Completed
- Conditions
- Glioblastoma MultiformeCytomegalovirus Infection
- Interventions
- Other: Placebo
- Registration Number
- NCT00400322
- Lead Sponsor
- Karolinska Institutet
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
Inclusion Criteria
- Glioblastoma grade IV
- Cytomegalovirus detected in tumor
- At least 90% resection of tumor
Exclusion Criteria
- Decreased kidney function
- Pregnancy
- Neutropenia
- Thrombocytopenia
- Patient not tolerating the drug
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Valganciclovir Valganciclovir (Valcyte) - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Tumor size Week twenty four
- Secondary Outcome Measures
Name Time Method Disease status 24 months Patient survival 24 months
Trial Locations
- Locations (3)
Department of Oncology, Norrland University Hospital
🇸🇪Umea, Sweden
Department of Oncology, Akademiska Hospital
🇸🇪Uppsala, Sweden
Department of neurosurgery, Karolinska University Hospital
🇸🇪Solna, Stockholm, Sweden