Evaluating Valganciclovir for Glioblastoma Treatment
A Multicenter Randomized Double-blinded Controlled Phase 2 Study Evaluating the Efficacy of Valganciclovir As Add-on Therapy in Glioblastoma Patients
This study is testing if adding a medication called valganciclovir to standard treatment can help people with glioblastoma fight their cancer better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Drugs / interventions | radiation |
| Locations | 3 sites (Oslo and 2 other locations) |
| Trial ID | NCT04116411 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized, double-blinded phase 2 trial assesses the efficacy and safety of valganciclovir as an add-on therapy for patients with glioblastoma. Participants will receive standard treatment with temozolomide and radiation therapy, combined with either placebo or valganciclovir. The study aims to determine if valganciclovir, known for treating cytomegalovirus infections, can also provide anti-tumoral effects in glioblastoma patients. Patients will be monitored for treatment response and safety over a period of 24 months.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed glioblastoma who have undergone radical resection and are able to participate in the study procedures.
Not a fit: Patients with non-newly diagnosed glioblastoma or those who have not undergone radical resection may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve outcomes for glioblastoma patients by potentially enhancing the effectiveness of standard therapies.
How similar studies have performed: While the use of valganciclovir in glioblastoma is a novel approach, previous studies have indicated potential benefits of targeting cytomegalovirus in tumor biology.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Oslo and 2 other locations
- Oslo University Hospital — Oslo, Norway (Recruiting)
- Stavanger University Hospital — Stavanger, Norway (Recruiting)
- SE01 Karolinska University Hospital — Solna, Stockholm, Sweden (Recruiting)
Study contacts
- Principal investigator: Giuseppe Stragliotto, MD, PhD — Karolinska University Hospital
- Study coordinator: Cecilia Soderberg-Naucler, MD, PhD
- Email: cecilia.naucler@ki.se
- Phone: +46702427471
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.