A Clinical Trial Evaluating the Efficacy of Valganciclovir in Glioblastoma Patients — VIGAS2  

Glioblastoma Multiforme Clinical Trial

Official title: A Multicenter Randomized Double-blinded Controlled Phase 2 Study Evaluating the Efficacy of Valganciclovir as add-on Therapy in Glioblastoma Patients

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Adult patients will either be randomized to standard treatment (temozolomide and radiation therapy) + placebo tablets or to standard treatment + valganciclovir. Patients are randomized using 1 to 1 distribution of the patients between the treatment groups and are stratified according to methylation status of the MGMT promoter; equal proportion of patients are included in each group. A maximum of 30% of patients with methylated MGMT promoter are allowed into the study (to harmonise with current data used for statistical power calculation), as MGMT promotor methylation status is prognostic for patient survival. Patients must enter the study within 10 weeks after surgery.

Full dose treatment with 900mgs of Valganciclovir is given twice daily for 6 weeks, thereafter 900 mgs daily during 98 weeks (total treatment of 24 months). Valganciclovir is available in 450 mg tablets. The dose of Valganciclovir will be adjusted according to renal function.

This study will be performed in compliance with the protocol, ICH-GCP, the declaration of Helsinki and applicable Swedish regulatory requirements.

The study discontinuation criteria are as follows:

• Withdrawal of consent

• An adverse event which requires discontinuation of the trial medication or results in

• inability to continue to comply with trial procedures

• Disease progression which results in inability to continue to comply with trial

• procedures

• Major Protocol deviations

• Exclusion criteria met ;

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

• NCT number: NCT04116411
• Study type: Interventional
• Source: Karolinska Institutet
• Contact: Cecilia Soderberg-Naucler, MD, PhD
• Phone: +46702427471
• Email: cecilia.naucler@ki.se
• Status: Recruiting
• Phase: Phase 2
• Start date: September 4, 2019
• Completion date: August 31, 2024