Alemtuzumab in Treating Patients With Waldenstrom's Macroglobulinemia
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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Campath-1H in Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia)|
- Objective response [ Designated as safety issue: No ]
- Time to treatment failure [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
|Study Start Date:||January 2004|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00081068
|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|
|Massachusetts General Hospital Cancer Center|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|United States, New York|
|Long Island Jewish Medical Center|
|New Hyde Park, New York, United States, 11040|
|Herbert Irving Comprehensive Cancer Center at Columbia University|
|New York, New York, United States, 10032|
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Peter MacCallum Cancer Centre|
|East Melbourne, Victoria, Australia, 3002|
|McMaster Children's Hospital at Hamilton Health Sciences|
|Hamilton, Ontario, Canada, ON L8N 3Z5|
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2C1|
|Centre Hospitalier Lens|
|Lens, France, 62307|
|Saint Bartholomew's Hospital|
|London, England, United Kingdom, EC1A 7BE|
|Study Chair:||Jennifer Gansert, MD, PhD||Jonsson Comprehensive Cancer Center|