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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Masking
NONE
Comprehensive Cancer Institute
Decatur, Alabama, United States
Comprehensive Cancer Institute
Huntsville, Alabama, United States
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.