EUCTR2005-003254-10-GB
Active, not recruiting
Phase 1
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 sites25 target enrollmentMay 15, 2009
DrugsTreosulfan
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity College London
- Enrollment
- 25
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
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
Outcomes
Primary Outcomes
Not specified
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