Myelodysplastic Syndromes Clinical Trial
Official title:
A Phase II Study of Sunitinib Malate (Sutent®; SU11248) in Patients With Intermediate-2 or High-Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia
This phase II trial is studying how well sunitinib works in treating patients with myelodysplastic syndromes or chronic myelomonocytic leukemia. Sunitinib may stop the growth of abnormal cells by blocking some of the enzymes needed for cell growth.
OBJECTIVES:
I. Determine the overall response rate (complete response, partial response, or hematological
improvement) in patients with intermediate-2 or high-risk myelodysplastic syndromes or
chronic myelomonocytic leukemia treated with sunitinib malate.
II. Determine the duration of response in patients treated with this drug. III. Determine the
overall survival of patients treated with this drug. IV. Determine the progression-free
survival of patients treated with this drug. V. Determine the time to disease progression in
patients treated with this drug.
VI. Determine the toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 4 weeks
in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 3-4 weeks and then monthly
thereafter.
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