NCT00225992

Phase II Research Study of Arsenic Trioxide (Trisenox) in Patients With Myelodysplastic Syndrome (MDS)

A Phase II Research Study of Arsenic Trioxide (Trisenox) in Patients With Myelodysplastic Syndrome (MDS)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Oncology Specialties, Alabama · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: —

Summary

In this phase II study besides evaluating for safety, the primary efficacy parameter is to evaluate the incidence of patients who have had a response to Trisenox by evidence of increased blood counts (red, white, or platelets) and/or by decrease or transfusion dependency. The secondary efficacy parameter is the assessment of the tolerability of the new dosing schedule. Arsenic trioxide will be administered intravenously over 1 to 2 hours with a loading dose of 0.30mg/kg for days 1-5 of the first week and then twice weekly for 27 weeks for a total of 28 weeks.

Conditions

• Myelodysplastic Syndrome (MDS)

Interventions

Type	Name	Description
DRUG	Arsenic Trioxide

Timeline

• Start date: 2004-02-01
• Primary completion: 2007-11-01
• Completion: 2007-11-01
• First posted: 2005-09-26
• Last updated: 2012-10-11

Locations

2 sites across 1 country: United States