Status:
ACTIVE_NOT_RECRUITING
A Clinical Trial Evaluating the Efficacy of Valganciclovir in Glioblastoma Patients
Lead Sponsor:
Cecilia Soderberg-Naucler
Collaborating Sponsors:
Karolinska University Hospital
Karolinska Institutet
Conditions:
Glioblastoma Multiforme
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 glio...
Detailed 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 di...
Eligibility Criteria
Inclusion
- Patients aged 18 years or older
- Patients with newly diagnosed glioblastoma, IDH 1 wt, WHO grade IV
- Radical resection
- Concomitant treatment with temozolomide and radiation therapy
- MGMT promoter methylation status
- Patients with at least KPS 70 , ECOG/WHO 2
- Patients providing written informed consent
- Patients cooperative and able to complete all the assessment procedures.
- 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.
- Patients must be enrolled within 10 weeks after surgery
Exclusion
- Patients allergic to, or who do not tolerate Valganciclovir, aciclovir or valaciclovir treatment
- Patients with decreased cognitive function (below 24 in MMSE test)
- Pregnant or lactating females
- Patients not signing informed consent
- Patient is simultaneously participating in another experimental drug therapy trial
- Neutrophil count \< 1,5 cells/ 109/L
- Platelet count \< 150 cells/ 109/L
- HGB \< 80 g/L
- Abnormal renal function (GFR \< 30)
- Secondary glioblastoma, or glioblastoma IDH1 mutated.
- Unfit for any other reason judged by investigator
Key Trial Info
Start Date :
September 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 16 2027
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT04116411
Start Date
September 4 2019
End Date
September 16 2027
Last Update
December 22 2025
Active Locations (3)
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1
Oslo University Hospital
Oslo, Norway
2
Stavanger University Hospital
Stavanger, Norway
3
SE01 Karolinska University Hospital
Solna, Stockholm County, Sweden, SE17164