Myelodysplastic Syndromes Clinical Trial
Official title:
A Phase II Pilot Study of VELCADE in Patients With MDS
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes
needed for cell growth.
PURPOSE: This phase II trial is studying how well bortezomib works in treating patients with
myelodysplastic syndromes.
OBJECTIVES:
Primary
- Determine the efficacy of bortezomib, in terms of reduced cytopenia, in patients with
myelodysplastic syndromes.
- Determine the safety and toxic effects of this drug in these patients.
Secondary
- Determine changes in marrow blast percentage or karyotypic profile in patients treated
with this drug.
OUTLINE: This is an open-label study.
Patients receive bortezomib IV on days 1, 4, 8, and 11. Treatment repeats every 21 days for
up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 1 year.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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