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Sponsors and Collaborators: |
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004889 |
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase II trial to study the effectiveness of rituximab in treating patients who have Waldenstrom's macroglobulinemia.
Condition | Intervention | Phase |
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Lymphoma |
Biological: rituximab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase II Study of Rituximab (Rituxan, Mabthera) in Waldenstrom's Macroglobulinemia |
Study Start Date: | December 1999 |
OBJECTIVES: I. Determine the objective response, time to treatment failure, and toxicity in patients with Waldenstrom's macroglobulinemia treated with rituximab. II. Correlate expression and changes in expression of CD20 on patient plasma cells and B-cells with clinical responses.
OUTLINE: This is a multicenter study. Patients receive rituximab IV weekly for 4 weeks. Treatment may be repeated 2 months later in patients with stable disease, partial response, or complete response. Patients are followed every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 12-25 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: Waldenstrom's macroglobulinemia No more than 2 prior courses of therapy No requirement for chemotherapy or steroid therapy for 90 days in previously untreated patients with slowly progressive disease
PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-2 Life expectancy: At least 6 months Hematopoietic: Absolute neutrophil count greater than 1,000/mm3 Platelet count greater than 25,000/mm3 Hepatic: Bilirubin less than 2.5 times upper limit of normal (ULN) SGOT less than 2.5 times ULN Renal: Creatinine less than 2.5 times ULN Other: Not pregnant or nursing Fertile patients must use effective contraception during and for 3 months after study No serious concurrent disease No concurrent uncontrolled bacterial, fungal, or viral infection No active second malignancy
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 30 days since prior chemotherapy Endocrine therapy: See Disease Characteristics At least 30 days since prior steroid therapy Radiotherapy: At least 30 days since prior radiotherapy Surgery: Not specified
United States, California | |
Cancer Center and Beckman Research Institute, City of Hope | |
Duarte, California, United States, 91010-3000 | |
Jonsson Comprehensive Cancer Center, UCLA | |
Los Angeles, California, United States, 90095-1781 | |
United States, District of Columbia | |
Walter Reed Army Medical Center | |
Washington, District of Columbia, United States, 20307-5000 | |
United States, Massachusetts | |
Brigham and Women's Hospital | |
Boston, Massachusetts, United States, 02115 | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
Massachusetts General Hospital Cancer Center | |
Boston, Massachusetts, United States, 02114 | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 | |
Canada, Alberta | |
Cross Cancer Institute | |
Edmonton, Alberta, Canada, T6G 1Z2 |
Study Chair: | Christos E. Emmanouilides, MD | Jonsson Comprehensive Cancer Center |
Study ID Numbers: | CDR0000067565, UCLA-9909016, NCI-G00-1709 |
Study First Received: | March 7, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00004889 History of Changes |
Health Authority: | United States: Federal Government |
Waldenstrom macroglobulinemia |
Immunoproliferative Disorders Immunologic Factors Rituximab Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Paraproteinemias |
Hemostatic Disorders Lymphatic Diseases Waldenstrom Macroglobulinemia Hemorrhagic Disorders Antirheumatic Agents Lymphoproliferative Disorders Lymphoma Neoplasms, Plasma Cell |
Neoplasms by Histologic Type Immunoproliferative Disorders Immunologic Factors Immune System Diseases Antineoplastic Agents Rituximab Hematologic Diseases Blood Protein Disorders Physiological Effects of Drugs Vascular Diseases Paraproteinemias Hemostatic Disorders |
Pharmacologic Actions Lymphatic Diseases Waldenstrom Macroglobulinemia Neoplasms Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases Antirheumatic Agents Lymphoproliferative Disorders Lymphoma Neoplasms, Plasma Cell |