Bortezomib and Vorinostat in Treating Patients With High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia
Part of paid clinical trials in Minneapolis, Minnesota.
- Sponsor
- Masonic Cancer Center, University of Minnesota
- Study ID
- NCT00818649
- Phase
- PHASE2
- Status
- Terminated
Conditions
- Leukemia
- Myelodysplastic Syndrome
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- bortezomib — DRUG1.3mg/m\^2 via peripheral subcutaneous administration on day 1, 4, 8, 11 of a 21 day cycle
- vorinostat — DRUG400 mg orally (po) every day on days 1-14 of a 21 day cycle
Study Details
RATIONALE: Bortezomib and vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving bortezomib together with vorinostat may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving bortezomib together with vorinostat works in treating patients with high-risk myelodysplastic syndrome or acute myelogenous leukemia.
Key Dates
- Start date
- Jan 31, 2009
- Status verified
- Dec 2017
- Primary completion
- May 31, 2012
- Completion
- May 31, 2012
Study Design
- Enrollment
- 16 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Velcade + VorinostatThis is a phase II two stage single arm study combining Velcade on days 1, 4, 8, and 11 plus oral Vorinostat days 1-14 of a 21 days cycle. Treatment will continue for a total of 3 treatment cycles.
Primary Outcome Measure
Number of Patients by Best Clinical Response [ Time Frame: At Completion of Course 3 (Day 63) ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Masonic Cancer Center, University of Minnesota | Minneapolis | Minnesota | 55455 | - |
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