EUCTR2017-000801-19-IT进行中（未招募）1 期
An interventional, open-label, Phase II study, to evaluate safety and efficacy of standard and high-dose chemotherapy associated with craniospinal irradiation in patients with metastatic medulloblastoma and other embryonal tumours - MBMET_MEYER2017
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Histologically confirmed, newly diagnosed, no previously treated patients with metastatic MB and other embryonal tumours (supratentorial primitive neuro-ectodermal tumors (sPNET) and pinealoblastoma, anaplastic large cell or partial resecate medulloblastoma (residue volume > 1,5 cm2), according to WHO 2007 classification. Patients underwent surgery
- •2. Males and females aged >3 years and <21 years;
- •3. Life expectancy = 4 weeks
- •4. Karnofsky / Lansky = 40%
- •5. Adequate hematological function (leucocyte = 2.0 x 10^9/l - Hemoglobin = 10 g/dl - platelet = 50 x 10^9 /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 obtained from the patient/parents or legal representative;
- •9. 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
排除标准
- •1. Any disease or condition that contraindicates the use of the study treatment (es. serious mental retardation, brain palsy, congenital syndrome, cardiomyopathy)
- •2. Administration of anti-cancer therapy concomitantly to the study enrolment
- •3. Concomitant partecipation to other clinical trial
- •4. Pregnancy or breastfeeding
- •5. Non adequate contraception
- •6. Hypersensibility to active principles or excipients
- •7. Severe bone-marrow depression
- •8. Concomitant use of yellow fever vaccine or other live vaccines
- •9. Other contraindications reported in the SmPC
研究者
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