A Phase II Trial of Combination Therapy With Arsenic Trioxide (Trisenox) and Gemtuzumab Ozogamicin (Mylotarg) for the Treatment of Adult Patients With Advanced Myelodysplastic Syndrome
- Determine the efficacy of arsenic trioxide and gemtuzumab ozogamicin to achieve
complete and partial remissions in patients with advanced myelodysplastic syndromes.
- Determine the efficacy of this regimen, in terms of 50% decrease in RBC transfusion
requirements and change in hemoglobin concentration from baseline in patients treated
with this regimen.
- Determine the platelet, neutrophil, bone marrow, and cytogenic response in patients
treated with this regimen.
- Determine the response duration in patients treated with this regimen.
- Determine the quality of life of patients treated with this regimen.
- Determine the safety and toxicity of this regimen in these patients.
OUTLINE: This is a multicenter, open-label study.
Patients receive arsenic trioxide IV over 1 hour once daily on days 1-5 in week 1 and then
twice weekly in weeks 2-12. They also receive gemtuzumab ozogamicin IV over 2 hours on day
8. Treatment repeats every 12 weeks for up to 2 courses in the absence of disease
progression or unacceptable toxicity.
Quality of life is assessed at baseline, every 12 weeks during study treatment, and then 4
weeks after the completion of study treatment.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete and partial remission
at 12 weeks post treatment
Mikkael A. Sekeres, MD, MS
The Cleveland Clinic
United States: Federal Government
|Cleveland Clinic Taussig Cancer Center||Cleveland, Ohio 44195|