An open-label, single-center, single-arm Phase II study to evaluate safety and efficacy of doxorubicin in combination with radiotherapy, temozolomide and valproic acid in patients with glioblastoma multiforme (GBM) and diffuse intrinsic pontine glioma (DIPG). - GMBTMZ/DOX2015

AZIENDA OSPEDALIERO-UNIVERSITARIA MEYER0 个研究点目标入组 20 人开始时间: 2020年11月4日最近更新: 2021年1月5日

试验速览

暂无简介。

•Males and females patients, aged >3 years and < 30 years;
•Histologically confirmed newly diagnosed glioblastoma multiforme, diffuse intrisic pontine glioma, diffuse glioma of the brain stem and spinal cord, bilateral thalamic glioma, gliomatosis cerebri, anaplastic astrocytoma;
•Patients undergone either surgery or biopsy only;
•No prior chemotherapy and/or radiotherapy;
•Life expectancy = 4 weeks;
•Karnofsky/Lansky = 40 %;
•Written informed consent obtained from the patient/parents or legal representative;
•Adequate hematological function (leucocyte = 2.0 x 10^9/l - Hemoglobin = 10 g/dl - platelet = 50 x 10^9 /l);
•Adequate liver function (total bilirubin = 2.5 x ULN - ALT/AST = 5.0 x ULN);
•Adequate renal function (serum creatinine = 1.5 x ULN);
•Availability to trial treatment and ability to be compliant with the protocol
•Are the trial subjects under 18? yes
•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 2
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Any disease or condition that contraindicates the use of the study treatment (es. serious mental retardation, brain palsy, congenital syndrome, cardiomyopathy)
•Prior anti-cancer therapy
•Pregnancy or breastfeeding
•Non adequate contraception

发起方