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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Merck |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00810576 |
Primary Objectives:
Secondary Objectives:
Condition | Intervention | Phase |
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Lymphoma |
Drug: Vorinostat Drug: Bortezomib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 40 |
Study Start Date: | January 2009 |
Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Vorinostat + Bortezomib (Velcade®)
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Drug: Vorinostat
Dose of 200 mg by mouth twice daily on days 1-14 of each 21-day study.
Drug: Bortezomib
Dose of 1.3 mg/m^2 by vein on days 1, 4, 8, and 11 of a 21 day cycle.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Barbara Pro, MD | 713-792-2860 |
United States, Texas | |
UT MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Barbara Pro, MD | UT MD Anderson Cancer Center |
Responsible Party: | UT MD Anderson Cancer Center ( Barbara Pro, MD/Associate Professor ) |
Study ID Numbers: | 2007-0658 |
Study First Received: | December 16, 2008 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00810576 History of Changes |
Health Authority: | United States: Institutional Review Board |
Relapsed T-Cell Non-Hodgkin's Lymphoma Refractory T-Cell Non-Hodgkin's Lymphoma NHL T-cell NHL vorinostat SAHA Suberoylanilide Hydroxamic Acid MSK-390 Zolinza Bortezomib Velcade |
LDP-341 MLN341 PS-341 Peripheral T-cell lymphoma CD 30 + anaplastic large cell lymphoma Angioimmunoblastic T-cell lymphoma Angiocentric/nasal type T/NK-cell lymphoma Intestinal T-cell lymphoma Hepatosplenic gamma delta T-cell lymphoma Subcutaneous panniculitic T-cell lymphoma Transformed Mycosis fungoides |
Anticarcinogenic Agents Anti-Inflammatory Agents Sezary Syndrome Mycosis Fungoides Lymphoma, T-Cell, Peripheral Lymphoma, Small Cleaved-cell, Diffuse Mycoses Enteropathy-associated T-cell Lymphoma Cutaneous T-cell Lymphoma Lymphoma, T-Cell Lymphoma, Large-Cell, Anaplastic Anti-Inflammatory Agents, Non-Steroidal Analgesics Lymphoma, Large-cell Lymphoma |
Lymphoma, Large B-Cell, Diffuse Peripheral T-cell Lymphoma Immunoproliferative Disorders Immunoblastic Lymphadenopathy Vorinostat Bortezomib Protease Inhibitors Lymphatic Diseases Analgesics, Non-Narcotic Peripheral Nervous System Agents Antirheumatic Agents Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Anaplastic Large Cell Lymphoma |
Anti-Inflammatory Agents Anticarcinogenic Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Sensory System Agents Lymphoma, T-Cell Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Lymphoma Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases |
Bortezomib Vorinostat Enzyme Inhibitors Protective Agents Pharmacologic Actions Protease Inhibitors Lymphatic Diseases Neoplasms Analgesics, Non-Narcotic Peripheral Nervous System Agents Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Antirheumatic Agents Central Nervous System Agents |