Combination of Vorinostat and Bortezomib in Relapsed or Refractory T-Cell Non-Hodgkin's Lymphoma
|ClinicalTrials.gov Identifier: NCT00810576|
Recruitment Status : Terminated (Terminated due to slow accrual.)
First Posted : December 18, 2008
Results First Posted : July 9, 2010
Last Update Posted : August 7, 2012
- To evaluate the response rate for patients with T-cell Non-Hodgkin's Lymphoma (NHL)receiving the combination of vorinostat and bortezomib
- To evaluate the safety and tolerability of the combination of vorinostat and bortezomib in patients with relapsed or refractory T-cell NHL.
- To assess overall survival and time to treatment failure in patients with T-cell NHL treated with the combination of vorinostat and bortezomib.
- Correlative studies will be done to assess the role of vorinostat mediated apoptosis along with bortezomib synergy. Changes in marker expression from baseline to post treatment will be correlated with patient clinical response.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: Vorinostat Drug: Bortezomib||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study To Determine The Safety and Efficacy Of The Combination of Vorinostat and Bortezomib In Patients With Relapsed Or Refractory T-Cell Non-Hodgkin's Lymphoma|
|Study Start Date :||January 2009|
|Primary Completion Date :||April 2010|
|Study Completion Date :||April 2010|
Experimental: Vorinostat + Bortezomib
Vorinostat 200 mg orally twice on Days 1-14 + Bortezomib 1.3 mg/m^2 intravenous (IV) on Days 1, 4, 8, 11.
Dose of 200 mg by mouth twice daily on days 1-14 of each 21-day study.
Other Names:Drug: Bortezomib
Dose of 1.3 mg/m^2 by vein on days 1, 4, 8, and 11 of a 21 day cycle.
- Number of Patients With Response [ Time Frame: Every two 21-day cycles ]Computed tomography scans and/or Positron emission tomography (PET) scans obtained every two cycles to evaluate response using International Workshop Criteria of Complete Response, Partial Response, Progressive Disease, or Stable Disease.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00810576
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Barbara Pro, MD||UT MD Anderson Cancer Center|