OTIS

• Research type

  Research Study

• Full title

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

• IRAS ID

  13691

• Sponsor organisation

  University College London

• Eudract number

  2005-003254-10

• ISRCTN Number

  ISRCTN11631773

• Research summary

  There are approximately 80 cases of Ewing??s Sarcoma (ES) each year in the UK. Currently, the treatment options available for patients with advanced (recurrent or resistant) ES are very limited. This study will explore the use of an oral drug, treosulfan, for the treatment of patients with advanced ES. Oral treosulfan has been used for many years in the treatment of ovarian cancer, but there is currently no data available for the treatment of ES. The primary aim of this study is to determine the efficacy and toxicity associated with the use of oral treosulfan in ES. 25 patients will be recruited in this study, over 6 sites, all in the UK. Treatment will involve taking oral treosulfan, which comes in a capsule form, 3 times a day over 7 days. This will be repeated every 28 days until the patient withdraws due to progression of disease, unacceptable toxicity, patient refusal or complete response. This study is being funded by the Adam Dealey Foundation and medac International

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  09/H0405/29

• Date of REC Opinion

  7 Aug 2009

• REC opinion

  Further Information Favourable Opinion