Phase II, single-arm, open-label interventional clinical trial to evaluate the role of anthracycline infusion after radiotherapy (RT) in pediatric and young adult patients with glioblastoma (pGBM) - Clinical Trial on glioblastoma with doxorubicin chemotherapy after radiotherapy

AZIENDA OSPEDALIERO-UNIVERSITARIA MEYER0 个研究点目标入组 20 人开始时间: 2021年5月24日最近更新: 2021年8月30日

适应症

试验速览

暂无简介。

•1. Patients with glioblastoma, first diagnosed not previously treated (with chemotherapy and radiotherapy) or treated only surgically
•2. Males and females between the ages of 3 and 30
•3. Life expectancy > or = 12 months
•4. Karnofsky / Lansky > or = 80%
•5. Adequate haematological function:
•¿ Absolute white blood cell count >= 2.0 x 10^9 / l
•¿ Hemoglobin >= 10 g / dl
•¿ Platelet count >= 50 x 109 / l
•6. Adequate liver function:
•¿ Total bilirubin <= 2.5 x ULN
•¿ ALT / AST <= 5.0 x ULN
•7. Adequate renal function:
•¿ Serum creatinine <= 1.5 x ULN
•8. Written informed consent from the patient, parents or legal guardians
•9. Patient availability during treatment and ability to comply 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

•1. Evidence of any other serious illness or condition that is a contraindication to study therapy (e.g. severe mental retardation, severe cerebral palsy, severe congenital syndromes, heart disease)
•2. Perform a 1st line chemotherapy cycle at the same time as the start of the study
•3. Simultaneous participation in other research projects
•4. State of pregnancy or breastfeeding
•5. Use of inadequate contraceptive methods

发起方