A phase II study to determine the efficacy and safety of conventional dose oral treosulfan in patients with advanced pre-treated Ewing's sarcoma

niversity College London (UK)0 个研究点目标入组 21 人开始时间: 2008年12月17日最近更新: 2022年2月7日

适应症

试验速览

•Current inclusion criteria as of 29/11/2011:
•1. Age less than 50 years, either sex
•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 Response Evaluation Criteria in Solid Tumors (RECIST)
•5. Evidence of disease progression within the preceding 8 weeks
•6. Neutrophils greater than or equal to 1.5 x 10^9/l and platelet count greater than or equal to 100 x 10^9/l
•7. Creatinine less than or equal to 1.5 x upper limit of normal (ULN)
•8. Serum bilirubin and aspartate aminotransferase (AST)/alanine aminotransferase (ALT) less than or equal to 1.5 x ULN
•9. Performance status 0-2 (patients 16 years or older) or Lansky Performance Status greater than 30 (patients under 16 years). (n.b. patients with WHO performance status 3 due to spinal disease will be eligible provided they are otherwise medically well)
•10. Patient able to comply with protocol treatment (swallow capsules) and follow up
•11. Life expectancy of three months or greater
•12. Written informed consent of patient or parent/legal guardian
•Previous inclusion criteria:
•9. World Health Organization (WHO) performance status greater than 3 (patients greater than 16 years); or Lansky Performance Status greater than 30

•1. Newly diagnosed, or resectable Ewing's sarcoma
•2. Pregnant/lactating women, or women of childbearing 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 (UK)