Leukemia Clinical Trial
Official title:
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
RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide and gemtuzumab ozogamicin,
work in different ways to stop the growth of cancer cells, either by killing the cells or by
stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill
more cancer cells.
PURPOSE: This phase II trial is studying how well giving arsenic trioxide together with
gemtuzumab ozogamicin works in treating patients with advanced myelodysplastic syndromes.
OBJECTIVES:
Primary
- Determine the efficacy of arsenic trioxide and gemtuzumab ozogamicin to achieve
complete and partial remissions in patients with advanced myelodysplastic syndromes.
Secondary
- Determine the efficacy of this regimen, in terms of 50% decrease in Red Blood Cell
(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
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