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Active, not recruiting Phase 2

A Clinical Trial Evaluating the Efficacy of Valganciclovir in Glioblastoma Patients

NCT04116411 · tracked via the Priya Life Science Sweden tracker
Sponsor
Cecilia Soderberg-Naucler
Phase
Phase 2
Started
2019-09-04
Last updated
2025-12-22

Condition(s) studied

Glioblastoma Multiforme

Investigational drug(s) / intervention(s)

Valganciclovir Tablets →Temozolomide 120 mg →Radiotherapy 60 GyPlacebo oral tablet

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Patients aged 18 years or older 2. Patients with newly diagnosed glioblastoma, IDH 1 wt, WHO grade IV 3. Radical resection 4. Concomitant treatment with temozolomide and radiation therapy 5. MGMT promoter methylation status 6. Patients with at least KPS 70 , ECOG/WHO 2 7. Patients providing written informed consent 8. Patients cooperative and able to complete all the assessment procedures. 9. Females of child-bearing age must have a negative pregnancy test at screening (all premenopausal women, or in case when menstrual status can not be ascertained in women under the age of 55). Female patient must agree to utilize a highly efficient birth control method throughout the study period (Pearl index \<1, e.g: oral contraception with gestagens, transdermal contraceptives, implants, injectables, intrauterine devices, bilateral tubal occlusion, sexual abstinence or vasectomised partner). The birth control method must be used at least 30 days after treatment end. Pregnancy testing should be performed at monthly intervals due to high teratogenic potential of valganciclovir. Men are recommended to use condoms with female partners during, and for at least 90 days following treatment with Valganciclovir. 10. Patients must be enrolled within 10 weeks after surgery Exclusion Criteria: 1. Patients allergic to, or who do not tolerate Valganciclovir, aciclovir or valaciclovir treatment 2. Patients with decreased cognitive function (below 24 in MMSE test) 3. Pregnant or lactating females 4. Patients not signing informed consent 5. Patient is simultaneously participating in another experimental drug therapy trial 6. Neutrophil count \< 1,5 cells/ 109/L 7. Platelet count \< 150 cells/ 109/L 8. HGB \< 80 g/L 9. Abnormal renal function (GFR \< 30) 10. Secondary glioblastoma, or glioblastoma IDH1 mutated. 11. Unfit for any other reason judged by investigator

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)

FacilityCityRegionStatus
Oslo University Hospital Oslo Norway
Stavanger University Hospital Stavanger Norway
SE01 Karolinska University Hospital Solna Stockholm County
Official registry record

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