A multicenter randomized double-blinded controlled phase 2 study evaluating the efficacy of valganciclovir as add-on therapy in glioblastoma patients

Karolinska Institutet0 个研究点目标入组 220 人开始时间: 2019年4月3日最近更新: 2021年10月8日

适应症

试验速览

暂无简介。

•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

•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

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