|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Merck |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00810576 |
Purpose
Primary Objectives:
Secondary Objectives:
| Condition | Intervention | Phase |
|---|---|---|
|
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 |
|---|---|
|
Vorinostat + Bortezomib: Experimental
Vorinostat 200 mg orally 2 x on Days 1-14 + Bortezomib 1.3 mg/m^2 IV on Days 1, 4, 8, 11.
|
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.
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Barbara Pro, MD | 713-792-2860 |
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Barbara Pro, MD | |
| Principal Investigator: | Barbara Pro, MD | UT MD Anderson Cancer Center |
More Information
| 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 8, 2009 |
| 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 |
|
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 |