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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00376961 |
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 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. Giving rituximab together with combination chemotherapy and bortezomib may kill more cancer cells. Giving bortezomib as maintenance therapy may keep the cancer from progressing.
PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy and bortezomib followed by bortezomib alone works in treating patients with newly diagnosed mantle cell lymphoma.
Condition | Intervention | Phase |
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Lymphoma |
Drug: bortezomib Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: prednisone Drug: rituximab Drug: vincristine sulfate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Combination Rituximab-CHOP and Bortezomib (Velcade®) (R-CHOP-V) Induction Therapy Followed by Bortezomib Maintenance (VM) Therapy for Patients With Newly Diagnosed Mantle Cell Lymphoma |
Estimated Enrollment: | 60 |
Study Start Date: | August 2006 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
After completion of study treatment, patients are followed periodically for 4 years and then annually for 3 years.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed mantle cell lymphoma (MCL) meeting the following criteria:
Confirmation of positivity for the following phenotypes by immunohistochemistry or flow cytometry:
Bidimensionally measurable disease by conventional techniques
Adequate tumor tissue from original diagnostic specimen available
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Study Chair: | Steven H. Bernstein, MD | James P. Wilmot Cancer Center |
Investigator: | Richard I. Fisher, MD | James P. Wilmot Cancer Center |
Study ID Numbers: | CDR0000494646, SWOG-S0601 |
Study First Received: | September 13, 2006 |
Last Updated: | January 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00376961 |
Health Authority: | United States: Federal Government |
contiguous stage II mantle cell lymphoma noncontiguous stage II mantle cell lymphoma stage III mantle cell lymphoma stage IV mantle cell lymphoma |
Prednisone Immunoproliferative Disorders Rituximab Lymphoma, Mantle-Cell Bortezomib Vincristine Cyclophosphamide |
Mantle cell lymphoma Doxorubicin Lymphatic Diseases Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antibiotics, Antineoplastic Hormones Therapeutic Uses Alkylating Agents Neoplasms by Histologic Type Immune System Diseases Antineoplastic Agents, Hormonal |
Mitosis Modulators Enzyme Inhibitors Antimitotic Agents Immunosuppressive Agents Glucocorticoids Pharmacologic Actions Protease Inhibitors Neoplasms Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic |