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

Trial ID: NCT04116411

Interventional - Phase 2 - Active, not recruiting

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.

Conditions

• Glioblastoma Multiforme

Interventions

• Valganciclovir Tablets
• Temozolomide 120 mg
• Radiotherapy 60 Gy
• Placebo oral tablet

Eligibility

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

Sponsor

Cecilia Soderberg-Naucler, Karolinska University Hospital, Karolinska Institutet

Source: ClinicalTrials.gov

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