A clinical trial to evaluate the effect of the anti-viral drug Valganciclovir in brain tumor patients

Phase 1

• Conditions: 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.; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-001083-30-SE
• Lead Sponsor: Karolinska Institutet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-03
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 220

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.