Vorinostat After Stem Cell Transplant in Treating Patients With High-Risk Lymphoma
Part of paid clinical trials in Columbus, Ohio.
- Sponsor
- Ohio State University Comprehensive Cancer Center
- Study ID
- NCT00561418
- Phase
- PHASE1
- Status
- Completed
Conditions
- Lymphoma
- Small Intestine Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- vorinostat — DRUGVorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles.
- Correlative studies — OTHERLaboratory as well as quality of life correlative studies will be obtained at days +26 to +38 (at approximately 1 month post HSCT),days +56 to +66 (≈2 mos), and at Cycle 2 Day 1 (≈3 mos.), Cycle 3 Day 1 (≈4 mos.), Cycle 5 Day 1 (≈6 mos.),Cycle 7 Day 1 (≈8 mos.), and off study (ideally at ≈12 mos.)
Study Details
RATIONALE: Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth, and may stimulate the immune system to stop cancer cells from growing. PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat after stem cell transplant in treating patients with high-risk lymphoma.
Key Dates
- Start date
- Nov 30, 2007
- Status verified
- Jul 2015
- Primary completion
- Nov 30, 2012
- Completion
- May 31, 2013
Study Design
- Enrollment
- 23 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Vorinostat (SAHA)Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles with the dose escalations.
Primary Outcome Measure
Safety and Tolerability of Vorinostat (SAHA) After Autologous Stem Cell Transplantation [ Time Frame: Up to 3 years ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Ohio State University Medical Center | Columbus | Ohio | 43210 | - |
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