A Phase II Study of Arsenic Trioxide in Combination With 5-Azacitidine in Myelodysplastic Syndromes
- Determine the response rate in patients with myelodysplastic syndromes or chronic
myelomonocytic leukemia treated with azacitidine and arsenic trioxide.
- 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
PROJECTED ACCRUAL: A total of 19-41 patients will be accrued for this study within 18
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Response rate (overall and confirmed) as measured by International Working Group (IWG) standardized criteria for MDS at day 113 and then every 4 weeks until completion of study treatment
Robert K. Stuart, MD
Medical University of South Carolina
United States: Federal Government
|Hollings Cancer Center at Medical University of South Carolina||Charleston, South Carolina 29425|