Bortezomib in Treating Patients With Myelodysplastic Syndromes
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Pilot Study of VELCADE in Patients With MDS|
- Safety as measured by NCI toxicity criteria after every course [ Time Frame: For 21 days/course for up to 12 courses ] [ Designated as safety issue: Yes ]
- Efficacy as measured by improvement of cytopenias based on complete blood counts after every course [ Time Frame: 21 Days/course for up to 12 courses ] [ Designated as safety issue: No ]
- Marrow and karyotype response and in vitro correlates (apoptosis, proliferation, etc.) assessed with marrow aspirate and biopsy sampling at baseline, day 14, and after courses 3, 6, and 12 [ Time Frame: 21 Days/course for up to 12 courses ] [ Designated as safety issue: No ]
|Study Start Date:||May 2005|
|Study Completion Date:||October 2010|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
- 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.
- 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.
|United States, New York|
|James P. Wilmot Cancer Center at University of Rochester Medical Center|
|Rochester, New York, United States, 14642|
|Study Chair:||Jane L. Liesveld, MD||James P. Wilmot Cancer Center|