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

Phase 1

• Conditions: Advanced and pre-treated Ewing’s Sarcoma; MedDRA version: 9.1 Level: LLT Classification code 10015562 Term: Ewing's sarcoma metastatic; MedDRA version: 9.1 Level: PT Classification code 10015562 Term: Ewing's sarcoma metastatic; MedDRA version: 9.1 Level: PT Classification code 10015564 Term: Ewing's sarcoma recurrent; MedDRA version: 9.1 Level: LLT Classification code 10015564 Term: Ewing's sarcoma recurrent

• Registration Number: EUCTR2005-003254-10-GB
• Lead Sponsor: niversity College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-05-15
• Study Completion: 2013-05-21
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified