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Sponsors and Collaborators: |
H. Lee Moffitt Cancer Center and Research Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00703664 |
RATIONALE: Bortezomib and vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving bortezomib together with vorinostat may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving bortezomib together with vorinostat works in treating patients with recurrent mantle cell lymphoma or recurrent and/or refractory diffuse large B-cell lymphoma.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Drug: bortezomib Drug: vorinostat Procedure: immunohistochemistry staining method Procedure: laboratory biomarker analysis |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial of Bortezomib and Vorinostat in Mantle Cell and Diffuse Large B-Cell Lymphomas |
Estimated Enrollment: | 116 |
Study Start Date: | July 2008 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to prior autologous stem cell transplantation (yes vs no). Patients are assigned to 1 of 3 treatment cohorts.
Patients who experience a complete or partial response after at least 1 year of study therapy may discontinue treatment while remaining on study and then resume treatment at the time of disease progression.
Archival or recent biopsy tissue specimens are obtained at baseline for laboratory correlative studies. Samples are analyzed by IHC for expression of Rel A protein as a predictive marker of response.
After completion of study therapy, patients are followed periodically.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of 1 of the following:
Mantle cell lymphoma meeting the following criteria:
Diffuse large B-cell lymphoma meeting the following criteria:
At least 1 prior systemic therapy AND meets 1 of the following criteria:
Must have histological material available for pathologic review and correlative studies, including either of the following:
PATIENT CHARACTERISTICS:
No QTc interval > 470 msec
PRIOR CONCURRENT THERAPY:
United States, Florida | |
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Recruiting |
Tampa, Florida, United States, 33612-9497 | |
Contact: Clinical Trials Office - H. Lee Moffitt Cancer Center and Rese 800-456-7121 canceranswers@moffitt.org | |
United States, Georgia | |
Winship Cancer Institute of Emory University | Recruiting |
Atlanta, Georgia, United States, 30322 | |
Contact: Mary Jo Lechowicz, MD 404-778-3908 mary_jo_lechowicz@emoryhealthcare.org | |
United States, North Carolina | |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Recruiting |
Chapel Hill, North Carolina, United States, 27599-7295 | |
Contact: Clinical Trials Office - Lineberger Comprehensive Cancer Cente 877-668-0683; 919-966-4432 | |
United States, Tennessee | |
Vanderbilt-Ingram Cancer Center | Recruiting |
Nashville, Tennessee, United States, 37232-6838 | |
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center 800-811-8480 | |
United States, Virginia | |
Virginia Commonwealth University Massey Cancer Center | Recruiting |
Richmond, Virginia, United States, 23298-0037 | |
Contact: Clinical Trials Office -Virginia Commonwealth University Masse 804-628-1939 |
Study Chair: | Lubomir Sokol, MD, PhD | H. Lee Moffitt Cancer Center and Research Institute |
Study ID Numbers: | CDR0000598308, MCC-15428, 8064 |
Study First Received: | June 20, 2008 |
Last Updated: | December 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00703664 |
Health Authority: | Unspecified |
recurrent mantle cell lymphoma recurrent adult diffuse large cell lymphoma |
Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Lymphoma, Mantle-Cell Bortezomib Vorinostat Mantle cell lymphoma Recurrence |
Lymphoma, B-Cell Lymphoma, large-cell Lymphatic Diseases B-cell lymphomas Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |
Anticarcinogenic Agents Anti-Inflammatory Agents Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Protective Agents Pharmacologic Actions |
Protease Inhibitors Neoplasms Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |