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Sponsors and Collaborators: |
Mayo Clinic Scottsdale National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00711828 |
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. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab and bortezomib together with combination chemotherapy may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving rituximab and cyclophosphamide together with bortezomib and dexamethasone works in treating patients with relapsed or refractory low-grade follicular lymphoma, Waldenstrom macroglobulinemia, or mantle cell lymphoma.
Condition | Intervention | Phase |
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Lymphoma |
Biological: rituximab Drug: bortezomib Drug: cyclophosphamide Drug: dexamethasone Other: questionnaire administration Procedure: quality-of-life assessment |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase 2 Clinical Trial of Rituximab, Cyclophosphamide, Bortezomib (VELCADE®), and Dexamethasone (R-CyBor-D) in Relapsed Low Grade and Mantle Cell Lymphoma |
Estimated Enrollment: | 36 |
Study Start Date: | October 2008 |
Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive rituximab IV on day 1, bortezomib IV on days 1, 4, 8, and 11, and oral cyclophosphamide and oral dexamethasone on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Patients complete a quality of life questionnaire (FACT/GOG neurotoxicity questionnaire, version 4.0) at baseline, on day 1 of courses 3, 6, and 9, and at the completion of study treatment.
After completion of study treatment, patients are followed every 3-6 months for up to 5 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed relapsed or refractory follicular lymphoma (grade I or II), mantle cell lymphoma (MCL), or lymphoplasmacytic lymphoma (Waldenstrom macroglobulinemia [WM])
Measurable disease, defined as lymph nodes ≥ 2.0 cm in at least one dimension by CT scan, PET/CT scan, or MRI
PATIENT CHARACTERISTICS:
No concurrent uncontrolled illness including, but not limited to, any of the following:
No other malignancy within the past 3 years, except for the following:
PRIOR CONCURRENT THERAPY:
United States, Arizona | |
Mayo Clinic Scottsdale | Recruiting |
Scottsdale, Arizona, United States, 85259-5499 | |
Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 |
Principal Investigator: | Craig B. Reeder, MD | Mayo Clinic Scottsdale |
Responsible Party: | Mayo Clinic Scottsdale ( Craig B. Reeder ) |
Study ID Numbers: | CDR0000600003, MAYO-MC0883, MAYO-X05259 |
Study First Received: | July 8, 2008 |
Last Updated: | March 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00711828 History of Changes |
Health Authority: | Unspecified |
recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent mantle cell lymphoma Waldenstrom macroglobulinemia |
Anti-Inflammatory Agents Dexamethasone Immunologic Factors Blood Protein Disorders Hormone Antagonists Lymphoma, Mantle-Cell Hormones, Hormone Substitutes, and Hormone Antagonists Lymphoma, Follicular Antiemetics Paraproteinemias Mantle Cell Lymphoma Cyclophosphamide Hemostatic Disorders Hormones Follicular Lymphoma |
Hemorrhagic Disorders Alkylating Agents Lymphoma Dexamethasone acetate Immunoproliferative Disorders Antineoplastic Agents, Hormonal Hematologic Diseases Rituximab Blood Coagulation Disorders Bortezomib Vascular Diseases Glucocorticoids Immunosuppressive Agents Recurrence Protease Inhibitors |
Anti-Inflammatory Agents Dexamethasone Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Blood Protein Disorders Lymphoma, Mantle-Cell Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Lymphoma, Follicular Antiemetics Paraproteinemias Cyclophosphamide Hemostatic Disorders Hormones |
Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases Alkylating Agents Lymphoma Dexamethasone acetate Immunoproliferative Disorders Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Hematologic Diseases Rituximab Bortezomib Gastrointestinal Agents Vascular Diseases |