Oral Treosulfan In Ewing's Sarcoma

Phase 2

Completed

• Conditions: Ewing's sarcoma; Cancer; Malignant neoplasm of bone and articular cartilage of other and unspecified sites

• Registration Number: ISRCTN11631773
• Lead Sponsor: niversity College London (UK)

Brief Summary

2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25284019 results

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-12-17
• Study Completion: 2012-09-11
• Last Update Posted: 7 February 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Current primary outcomes measure as of 29/11/2011:<br> Objective response rate achieved: tumour response will be measured as defined by the RECIST guidelines.<br><br> Previous primary outcome measure:<br> Objective response rate achieved: tumour response will be measured as defined by the RECIST guidelines. Following analysis of data for initial 15 patients, if the measured success is less than or equal to 10% then the study will be stopped. Otherwise, the study will close once a total of 25 eligible patients have been enrolled.<br>