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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: | NCT00081068 |
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.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Drug: alemtuzumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study of Campath-1H in Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia) |
Study Start Date: | January 2004 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of Waldenstrom's macroglobulinemia (lymphoplasmacytic lymphoma)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, California | |
Jonsson Comprehensive Cancer Center at UCLA | |
Los Angeles, California, United States, 90095-1781 | |
United States, Colorado | |
Rocky Mountain Cancer Centers - Denver Midtown | |
Denver, Colorado, United States, 80218 | |
United States, Illinois | |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | |
Chicago, Illinois, United States, 60611-3013 | |
United States, Maryland | |
Greenebaum Cancer Center at University of Maryland Medical Center | |
Baltimore, Maryland, United States, 21201 | |
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02215 | |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
Massachusetts General Hospital Cancer Center | |
Boston, Massachusetts, United States, 02114 | |
United States, New York | |
Herbert Irving Comprehensive Cancer Center at Columbia University | |
New York, New York, United States, 10032 | |
Long Island Jewish Medical Center | |
New Hyde Park, New York, United States, 11040 | |
United States, Ohio | |
Cleveland Clinic Taussig Cancer Center | |
Cleveland, Ohio, United States, 44195 | |
Australia, Victoria | |
Peter MacCallum Cancer Centre | |
East Melbourne, Victoria, Australia, 3002 | |
Canada, Ontario | |
McMaster Children's Hospital at Hamilton Health Sciences | |
Hamilton, Ontario, Canada, ON L8N 3Z5 | |
Princess Margaret Hospital | |
Toronto, Ontario, Canada, M5G 2C1 | |
France | |
Centre Hospitalier Lens | |
Lens, France, 62307 | |
United Kingdom, England | |
Saint Bartholomew's Hospital | |
London, England, United Kingdom, EC1A 7BE |
Study Chair: | Jennifer Gansert, MD, PhD | Jonsson Comprehensive Cancer Center |
Study ID Numbers: | CDR0000358811, UCLA-0309058 |
Study First Received: | April 7, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00081068 |
Health Authority: | United States: Federal Government |
Waldenstrom macroglobulinemia |
Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Paraproteinemias Hemostatic Disorders Lymphatic Diseases |
Waldenstrom Macroglobulinemia Hemorrhagic Disorders Alemtuzumab Waldenstrom macroglobulinemia Lymphoproliferative Disorders Lymphoma Neoplasms, Plasma Cell |
Neoplasms Neoplasms by Histologic Type Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Cardiovascular Diseases Pharmacologic Actions |