Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
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
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Giuseppe Stragliotto, MD, PhD|
|Principal Investigator Affiliation||Karolinska University Hospital|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
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 distribution of the patients between the treatment groups and are stratified according to methylation status of the MGMT promoter; equal proportion of patients are included in each group. A maximum of 30% of patients with methylated MGMT promoter are allowed into the study (to harmonise with current data used for statistical power calculation), as MGMT promotor methylation status is prognostic for patient survival. Patients must enter the study within 10 weeks after surgery. Full dose treatment with 900mgs of Valganciclovir is given twice daily for 6 weeks, thereafter 900 mgs daily during 98 weeks (total treatment of 24 months). Valganciclovir is available in 450 mg tablets. The dose of Valganciclovir will be adjusted according to renal function. This study will be performed in compliance with the protocol, ICH-GCP, the declaration of Helsinki and applicable Swedish regulatory requirements. The study discontinuation criteria are as follows: - Withdrawal of consent - An adverse event which requires discontinuation of the trial medication or results in - inability to continue to comply with trial procedures - Disease progression which results in inability to continue to comply with trial - procedures - Major Protocol deviations - Exclusion criteria met
Placebo Comparator: Placebo
Patients will receive placebo tablets with similar appearance as the active drug. Patients receive two 450 mg tablets twice daily taken per orally for 6 weeks, thereafter one 450 mg tablet twice daily for an additional 22.5 months; a total treatment time of 24 months.
Active Comparator: Valganciclovir
Patients will receive valganciclovir tablets with similar appearance as the placebo tablets. Patients receive two 450 mg valganciclovir tablets twice daily taken per orally for 6 weeks, thereafter one 450 mg valganciclovir tablet twice daily for an additional 22.5 months; a total treatment time of 24 months.
Drug: - Valganciclovir Tablets
Valganciclovir treatment of glioblastoma
Drug: - Temozolomide 120 mg
Radiation: - Radiotherapy 60 Gy
Drug: - Placebo oral tablet
Placebo treatment of glioblastoma
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.