Spots Global Cancer Trial Database for Rituximab in Treating Patients With Waldenstrom's Macroglobulinemia
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Trial Identification
Brief Title: Rituximab in Treating Patients With Waldenstrom's Macroglobulinemia
Official Title: Phase II Study of Rituximab (Rituxan, Mabthera) in Waldenstrom's Macroglobulinemia
Study ID: NCT00004889
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Cancer Center and Beckman Research Institute, City of Hope, Duarte, California, United States
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States
Walter Reed Army Medical Center, Washington, District of Columbia, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
Brigham and Women's Hospital, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Cross Cancer Institute, Edmonton, Alberta, Canada
Contact Details
Name: Christos E. Emmanouilides, MD
Affiliation: Jonsson Comprehensive Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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