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A Clinical Trial Evaluating the Efficacy of Valganciclovir in Glioblastoma Patients (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.
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 moreAwards & 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.
Find a Location
Who is running the clinical trial?
Karolinska InstitutetOTHER
1,460 Previous Clinical Trials
31,646,569 Total Patients Enrolled
2 Trials studying Glioblastoma
242 Patients Enrolled for Glioblastoma
Cecilia Soderberg-NauclerLead Sponsor
Karolinska University HospitalOTHER
497 Previous Clinical Trials
1,316,007 Total Patients Enrolled
4 Trials studying Glioblastoma
251 Patients Enrolled for Glioblastoma
Giuseppe Stragliotto, MD, PhDPrincipal InvestigatorKarolinska University Hospital