Study of Carfilzomib and Vorinostat for Relapsed or Refractory Lymphoma
Part of paid clinical trials in Rochester, New York.
- Sponsor
- University of Rochester
- Study ID
- NCT01276717
- Phase
- PHASE1
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Drug: Carfilzomib — DRUGCarfilzomib 30 minutes infusion daily for days 1, 2, 8, 9, 15, 16, Every 28 days. A maximum of 13 cycles will be administered.
- Vorinostat — DRUGVorinostat by mouth twice daily on days 1, 2, 3, 8, 9, 10, 15, 16 and 17. Maximum 13 cycles.
Study Details
This will be a phase I study of carfilzomib in combination with vorinostat in patients with relapsed/refractory B-cell lymphomas. Combination therapy with proteosome inhibitor PR-171 and HDAC inhibitors is highly synergistic in primary DLBCL cells, and both classes of drugs can also synergize powerfully to induce cell death in bortezomib-resistant cells. The purpose of this study is to see if vorinostat can combine with carfilzomib and to safely find the recommended phase II dose.
Key Dates
- Start date
- Jan 31, 2011
- Status verified
- Dec 2015
- Primary completion
- Jul 31, 2013
- Completion
- Jan 31, 2015
Study Design
- Enrollment
- 20 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Vorinostat + Carfilzomib
Primary Outcome Measure
Number of Participants who experience Adverse Events as a Measure of Safety and Tolerability [ Time Frame: From date of study entry until the 30 days after the last dose of study treatment. ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Rochester | Rochester | New York | 14642 | - |
| Virginia Commonwealth University Massey Cancer Center | Richmond | Virginia | 23298 | - |
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