Skip to main content
Clinical Trials/EUCTR2005-003254-10-GB
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

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.

Registry
who.int
Start Date
May 15, 2009
End Date
May 21, 2013
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
niversity College London

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

Similar Trials