A Phase II Study to determine the efficacy and safety of conventional dose oral Treosulfan in patients with advanced pre-treated Ewing’s Sarcoma - OTIS

niversity College London0 个研究点目标入组 25 人开始时间: 2009年5月15日最近更新: 2019年11月25日

试验速览

暂无简介。

•1. Age 3 - 50 years
•2. Histologically proven Ewing’s sarcoma/Peripheral Neuroectodermal Tumour
•3. Patients with advanced, refractory disease who have failed at least one course of conventional chemotherapy and for whom no curative option exists.
•4 .Measurable disease, defined by RECIST
•5. Evidence of disease progression within the preceding 8 weeks
•6. Adequate blood counts and biochemical profile
•7. WHO Performance status 0-2 (patients > =16 years); or Lansky Performance Status > =30. (n.b. patients with WHO performance status 3 due to spinal disease will be eligible provided they are otherwise medically well)
•8. Patient able to comply with protocol treatment (swallow capsules) and follow up
•9. Life expectancy of 3 months or greater
•10. Written informed consent of patient or parent/legal guardian.
•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
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Newly diagnosed, or resectable Ewing’s sarcoma
•2. Pregnant/lactating women, or women of child bearing potential unless using effective contraception
•3. Concurrent treatment with any other anti-cancer therapy, except palliative radiotherapy to non-target lesions
•4. Concurrent treatment with other experimental drugs
•5. Concurrent treatment with growth factors

发起方

niversity College London