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Sponsored by: |
Sylvester Cancer Center |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00772668 |
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving rituximab together with cyclophosphamide, bortezomib, and prednisone may kill more cancer cells.
PURPOSE: This clinical trial is studying how well giving rituximab together with cyclophosphamide, bortezomib, and prednisone works as first-line therapy in treating patients with stage III or stage IV follicular lymphoma or marginal zone lymphoma.
Condition | Intervention |
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Lymphoma |
Drug: bortezomib Drug: cyclophosphamide Drug: prednisone Drug: rituximab |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Pilot Study of RCVELP as First Line Therapy for Follicular Lymphoma (FL) and Marginal Zone Lymphoma (MZL) |
Estimated Enrollment: | 30 |
Study Start Date: | September 2008 |
Estimated Primary Completion Date: | September 2015 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE:
After completion of study therapy, patients are followed every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.
Ages Eligible for Study: | 17 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed grade 1 or 2 follicular lymphoma (FL) or marginal zone lymphoma (MZL)
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Florida | |
University of Miami Sylvester Comprehensive Cancer Center - Miami | Recruiting |
Miami, Florida, United States, 33136 | |
Contact: University of Miami Sylvester Comprehensive Cancer Center Clin 866-574-5124 Sylvester@emergingmed.com |
Study Chair: | Denise Pereira, MD | Sylvester Cancer Center |
Responsible Party: | University of Miami Sylvester Comprehensive Cancer Center - Miami ( Clinical Trial Matching Service ) |
Study ID Numbers: | CDR0000616111, SCCC-2006120, SCCC-EPROST-20070963 |
Study First Received: | October 12, 2008 |
Last Updated: | December 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00772668 |
Health Authority: | Unspecified |
stage III grade 1 follicular lymphoma stage IV grade 1 follicular lymphoma stage III grade 2 follicular lymphoma |
stage IV grade 2 follicular lymphoma stage III marginal zone lymphoma stage IV marginal zone lymphoma |
Prednisone Lymphatic Diseases Immunoproliferative Disorders Rituximab Bortezomib Lymphoma, Follicular |
Cyclophosphamide Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Follicular lymphoma |
Anti-Inflammatory Agents Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Enzyme Inhibitors Hormones |
Glucocorticoids Immunosuppressive Agents Pharmacologic Actions Protease Inhibitors Neoplasms Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |