Evaluating Valganciclovir for Glioblastoma Treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Using FET-PET fused with MRI to better map and treat glioblastoma

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.