Leukemia Clinical Trial
Official title:
A Phase II Study of Arsenic Trioxide in Combination With 5-Azacitidine in Myelodysplastic Syndromes
RATIONALE: Drugs used in chemotherapy, such as azacitidine and arsenic trioxide, 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 azacitidine together with arsenic
trioxide works in treating patients with myelodysplastic syndromes or chronic myelomonocytic
leukemia.
OBJECTIVES:
Primary
- Determine the response rate in patients with myelodysplastic syndromes or chronic
myelomonocytic leukemia treated with azacitidine and arsenic trioxide.
Secondary
- Determine time to treatment failure in patients treated with this regimen.
- Determine the tolerability and toxicity of this regimen in these patients.
- Determine progression-free survival of patients treated with this regimen.
OUTLINE: This a multicenter, non-randomized, open-label, study.
Patients receive azacitidine subcutaneously once daily on days 1-5 and arsenic trioxide IV
over 1-2 hours on days 1, 2, 8, 9, 15, 16, 22, and 23. Treatment repeats every 28 days for 4
courses in the absence of disease progression or unacceptable toxicity. Patients are
evaluated for response on day 113 (week 17). Patients with disease progression or no response
are removed from the study. Patients achieving a complete response (CR) receive 2 additional
courses of therapy and then undergo observation. Patients achieving a partial response
receive 2 additional courses of therapy and then receive arsenic trioxide alone twice weekly
in the absence of CR, disease progression, or unacceptable toxicity.
After completion of study treatment, patients are followed every 2 months for at least 1
year.
PROJECTED ACCRUAL: A total of 19-41 patients will be accrued for this study within 18 months.
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