Alemtuzumab in Treating Patients With Waldenstrom's Macroglobulinemia
- Conditions
- Lymphoma
- Registration Number
- NCT00081068
- Lead Sponsor
- Jonsson Comprehensive Cancer Center
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective response Time to treatment failure Toxicity
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (15)
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Massachusetts General Hospital Cancer Center
🇺🇸Boston, Massachusetts, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Saint Bartholomew's Hospital
🇬🇧London, England, United Kingdom
Centre Hospitalier Lens
🇫🇷Lens, France
Jonsson Comprehensive Cancer Center at UCLA
🇺🇸Los Angeles, California, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
🇺🇸Chicago, Illinois, United States
Rocky Mountain Cancer Centers - Denver Midtown
🇺🇸Denver, Colorado, United States
Greenebaum Cancer Center at University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Peter MacCallum Cancer Centre
🇦🇺East Melbourne, Victoria, Australia
Herbert Irving Comprehensive Cancer Center at Columbia University
🇺🇸New York, New York, United States
McMaster Children's Hospital at Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Long Island Jewish Medical Center
🇺🇸New Hyde Park, New York, United States