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Valganciclovir for Glioblastoma (VIGAS2 Trial)

Phase 2

Recruiting

Led By Giuseppe Stragliotto, MD, PhD

Research Sponsored by Cecilia Soderberg-Naucler

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up study closure at 30 months follow up. survival analyses will be analysed at 12 and 24 months.

Awards & highlights

Approved for 10 Other Conditions

All Individual Drugs Already Approved

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.

Eligible Conditions

Glioblastoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ study closure at 30 months follow up. survival analyses will be analysed at 12 and 24 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~study closure at 30 months follow up. survival analyses will be analysed at 12 and 24 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and study closure at 30 months follow up. survival analyses will be analysed at 12 and 24 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Baseline and demographic data

Impact of valganciclovir on median overall survival of glioblastoma patients

Secondary study objectives

Cognitive functions

Health related Quality of Life using EORTC QLQ30 module

Health related Quality of Life using the EORTC BN20 module

+2 more

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: ValganciclovirActive Control3 Interventions

Patients will receive valganciclovir tablets with similar appearance as the placebo tablets. Patients receive two 450 mg valganciclovir tablets twice daily taken per orally for 6 weeks, thereafter two 450 mg valganciclovir tablets once daily for an additional 22.5 months; a total treatment time of 24 months.

Group II: PlaceboPlacebo Group3 Interventions

Patients will receive placebo tablets with similar appearance as the active drug. Patients receive two 450 mg tablets twice daily taken per orally for 6 weeks, thereafter two 450 mg tablet once daily for an additional 22.5 months; a total treatment time of 24 months.

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