Spots Global Cancer Trial Database for Alemtuzumab in Treating Patients With Waldenstrom's Macroglobulinemia
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Trial Identification
Brief Title: Alemtuzumab in Treating Patients With Waldenstrom's Macroglobulinemia
Official Title: Phase II Study of Campath-1H in Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia)
Study ID: NCT00081068
Conditions
Interventions
Study Description
Brief Summary: RATIONALE: Monoclonal antibodies, such as alemtuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: This phase II trial is studying how well alemtuzumab works in treating patients with Waldenstrom's macroglobulinemia.
Detailed Description: OBJECTIVES: * Determine the objective response in patients with Waldenstrom's macroglobulinemia treated with alemtuzumab. * Determine the time to treatment failure in patients treated with this drug. * Determine the toxicity of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive alemtuzumab IV over 2 hours on days 1, 3, and 5 of weeks 1-6 (course 1) in the absence of disease progression or unacceptable toxicity. Patients with a complete response undergo observation. Patients with stable disease or a minor or partial response receive an additional course of alemtuzumab, administered as in course 1, on weeks 7-12. Patients are followed every 6 months for 2 years. PROJECTED ACCRUAL: A total of 13-27 patients will be accrued for this study.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Jonsson Comprehensive Cancer Center at UCLA, Los Angeles, California, United States
Rocky Mountain Cancer Centers - Denver Midtown, Denver, Colorado, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, United States
Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Long Island Jewish Medical Center, New Hyde Park, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University, New York, New York, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia
McMaster Children's Hospital at Hamilton Health Sciences, Hamilton, Ontario, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
Centre Hospitalier Lens, Lens, , France
Saint Bartholomew's Hospital, London, England, United Kingdom
Contact Details
Name: Jennifer Gansert, MD, PhD
Affiliation: Jonsson Comprehensive Cancer Center
Role: STUDY_CHAIR
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