EUCTR2019-001083-30-SE
Active, not recruiting
Phase 1
A multicenter randomized double-blinded controlled phase 2 study evaluating the efficacy of valganciclovir as add-on therapy in glioblastoma patients
ConditionsGlioblastoma 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]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- 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.
- Sponsor
- Karolinska Institutet
- Enrollment
- 220
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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.
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.
Outcomes
Primary Outcomes
Not specified
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