Efficacy and Safety of Valcyte® as an Add-on Therapy in Patients With Malignant Glioblastoma and Cytomegalovirus (CMV) Infection
This trial is active, not recruiting.
|Conditions||glioblastoma multiforme, cytomegalovirus infection|
|Sponsor||Karolinska University Hospital|
|Start date||August 2006|
|End date||March 2009|
|Trial size||40 participants|
|Trial identifier||NCT00400322, Eudra CT: 2006-002022-29, MV20145|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Solna, Sweden||Department of neurosurgery, Karolinska University Hospital||no longer recruiting|
|Umea, Sweden||Department of Oncology, Norrland University Hospital||no longer recruiting|
|Uppsala, Sweden||Department of Oncology, Akademiska Hospital||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
time frame: week twelve and week twenty four
Male or female participants at least 18 years old.
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
|Official title||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.|
|Principal investigator||Inti Peredo, MD|
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