This trial is active, not recruiting.

Conditions glioblastoma multiforme, cytomegalovirus infection
Treatment valganciclovir (valcyte)
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

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose treatment

Primary Outcomes

Tumor size
time frame: week twelve and week twenty four

Secondary Outcomes

Disease status
time frame:
Patient survival
time frame:

Eligibility Criteria

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in January 2009.
Information provided to ClinicalTrials.gov by Karolinska University Hospital.