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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 |
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Lymphoma |
Drug: bortezomib Drug: vorinostat Other: immunohistochemistry staining method Other: 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 receive oral vorinostat once daily on days 1-5 and 8-12. Patients also receive bortezomib IV on days 1, 4, 8, and 11. Treatment repeats every 3 weeks in the absence of disease progression, unacceptable toxicity, or requirement for palliative irradiation. 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 (cohort 3) meeting 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: Lubomir Sokol, MD, PhD 813-745-8212 | |
United States, New York | |
Montefiore Medical Center | Recruiting |
Bronx, New York, United States, 10467-2490 | |
Contact: Samir S. Parekh, MD 718-920-4826 sparekh@montefiore.org | |
New York Weill Cornell Cancer Center at Cornell University | Recruiting |
New York, New York, United States, 10021 | |
Contact: Clinical Trials Office - New York Weill Cornell Cancer Center 212-746-1848 | |
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: | Steven Grant, MD | Massey Cancer Center |
Responsible Party: | H. Lee Moffitt Cancer Center and Research Institute at University of South Florida ( Daniel M. Sullivan ) |
Study ID Numbers: | CDR0000598308, MCC-15428, 8064 |
Study First Received: | June 20, 2008 |
Last Updated: | August 11, 2009 |
ClinicalTrials.gov Identifier: | NCT00703664 History of Changes |
Health Authority: | Unspecified |
recurrent mantle cell lymphoma recurrent adult diffuse large cell lymphoma |
Anticarcinogenic Agents Anti-Inflammatory Agents Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Lymphoma, Mantle-Cell Bortezomib Vorinostat Mantle Cell Lymphoma Recurrence Protease Inhibitors Lymphoma, B-Cell |
Lymphatic Diseases B-cell Lymphomas Analgesics, Non-Narcotic Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma, Large-cell Lymphoma |
Anticarcinogenic Agents Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Lymphoma, Mantle-Cell Physiological Effects of Drugs Lymphoma, B-Cell Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Lymphoma Lymphoma, Large B-Cell, Diffuse 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 Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Antirheumatic Agents Central Nervous System Agents |