A Clinical Trial Evaluating the Efficacy of Valganciclovir in Glioblastoma Patients
Condition(s) studied
Investigational drug(s) / intervention(s)
Valganciclovir Tablets: Valganciclovir treatment of glioblastoma
Temozolomide 120 mg: Chemotherapy
Radiotherapy 60 Gy: Radiation therapy
Placebo oral tablet: Placebo treatment of glioblastoma
Study summary
This study is a multicenter randomized double-blinded controlled phase 2 study evaluating the efficacy and safety of the anti-CMV drug valganciclovir vs placebo as add-on therapy in patients with glioblastoma. Valganciclovir is approved for treatment of cytomegalovirus (CMV) infections, but may also have anti-tumoral effects. Current evidence imply that most glioblastomas are CMV positive and that the virus can affect tumor aggressiveness.
Eligibility
Primary outcome measure(s)
- Impact of valganciclovir on median overall survival of glioblastoma patients — Study closure at 30 months follow up. Survival analyses will be analysed at 12 and 24 months.
Median overall survival will be analyzed using Cox regression analysis and presented by Kaplan-Meier graphs. Proportion of patients alive at 12 or 24 months, respectively, in each study arm and will be analyzed using Fisher exact test. - Baseline and demographic data — At 30 months follow up
All baseline and demographic data will be analysed using descriptive statistics such as mean, medians, standard deviations etc. for all variables which are continuous. Variables that are categorical will be analysed using frequency tables with number of patients and percent. All these analyses will be divided by treatment group. No formal hypothesis testing will be performed for the demographic and baseline variables.
Trial sites (3)
| Facility | City | Region | Status |
|---|---|---|---|
| Oslo University Hospital | Oslo | Norway | |
| Stavanger University Hospital | Stavanger | Norway | |
| SE01 Karolinska University Hospital | Solna | Stockholm County |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04116411 on ClinicalTrials.gov ↗ ← All trials in Sweden