Phase II Research Study of Arsenic Trioxide (Trisenox) in Patients With Myelodysplastic Syndrome (MDS)
Status:
Terminated
Trial end date:
2007-11-01
Target enrollment:
Participant gender:
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.