Glioblastoma is an incurable brain tumor with very dismal prognosis. Substantial evidence demonstrates that cytomegalovirus (CMV) is present in 90-100% of malignant glioblastoma.We have observed that valganciclovir is well tolerated among glioblastoma patients receiving temozolomide and radiation therapy. We further observed that treatment with valganciclovir may enhance the survival chances for glioblastoma patients. We aim to assess the efficacy of Valganciclovir in glioblastoma patients.
Conditions
Interventions
Product Name: valganciclovir
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Karolinska Institutet
Eligibility
Sex/Gender
All
Inclusion 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; no more than 1 cm3 remaining contrast enhancement tumor by MRI or CT, postoperatively. 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. Patient agrees to utilize two reliable methods of contraception combined throughout the study period. 10. Females of childbearing age potential must have a negative pregnancy test at screening. 11. Patients must be enrolled within 6 weeks after surgery Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
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 < 1500 cells/mm3l 7. Platelet count < 150 000 cells/ mm3 8. HGB < 8g/dL 9. Abnormal renal function (GFR < 30) 10. Secondary glioblastoma, or glioblastoma IDH1 mutated. 11. Unfit for any other reason judged by investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of Valganciclovir in glioblastoma patients.;Secondary Objective: Evaluate tumor volume, proportion of patients with stable / progressive disease, quality of life, safety aspects and subgroup analyzes regarding CMV status. ;Primary end point(s): Primary endpoint point: Median overall survival at 30 months follow up time.;Timepoint(s) of evaluation of this end point: 30 months follow up time after inclusion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Proportion of patients alive at 12 and 24 months • Overall progression free survival (RANO and NANO criteria) • Quality of life assessments (EORTC QoL questionnaire at base line and every three months at routine checkups (3, 6, 9, 12, 15 18, 21, 24 and 30 months) • Patient overall survival and median survival time (patients are followed until death). • Proportion of patients with progressive disease at 24 months (RANO criteria). • Proportion of patients with progressive disease at 24 months (Clinical and NANO criteria). • Proportion of patients with stable disease at 12 and 24 months (RANO criteria). • Proportion of patients with recurrence at 12 and 24 months • Continuous proportion of progressive disease • Continuous proportion of stable disease • Continuous proportion of patients with treatment failure • Subgroup analyses will be performed on CMV positive patients. • Safety assessements ;Timepoint(s) of evaluation of this end point: Tumor volume/ disease status assessments at 12 and 24 months, Quality of life assessments at:3, 6, 9, 12, 15, 18, 21, 24 och 30 months. | — |
Countries
Israel, Norway, Sweden, United States
Contacts
Public ContactKonstantinos Kostulas@sll.se
Karolinska University Hospital; SLL
Outcome results
None listed