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: Rituximab for Waldenstrom's Macroglobulinemia (WM): A Phase II Pilot Study for Untreated or Previously Treated Patients
Study ID: NCT00005609
Conditions
Interventions
Study Description
Brief Summary: RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and 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 response rate in previously treated and previously untreated patients with Waldenstrom's macroglobulinemia receiving rituximab. II. Determine the associated toxicities with this treatment, specifically the frequency of febrile or hypotensive events, in this patient population. OUTLINE: Patients are stratified according to prior treatment (yes vs no). Patients with prior treatment are further stratified according to type of treatment (alkylating agents vs purine nucleoside analogues). Patients receive rituximab IV over 4 hours on days 1, 8, 15, and 22. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 66 patients (33 per stratum) will be accrued for this study within 36 months.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
CCOP - Scottsdale Oncology Program, Scottsdale, Arizona, United States
Cancer Center and Beckman Research Institute, City of Hope, Duarte, California, United States
Veterans Affairs Medical Center - Palo Alto, Palo Alto, California, United States
Stanford University Medical Center, Stanford, California, United States
CCOP - Colorado Cancer Research Program, Inc., Denver, Colorado, United States
CCOP - Christiana Care Health Services, Wilmington, Delaware, United States
Walter Reed Army Medical Center, Washington, District of Columbia, United States
Veterans Affairs Medical Center - Gainsville, Gainesville, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Veterans Affairs Medical Center - Tampa (Haley), Tampa, Florida, United States
Emory University Hospital - Atlanta, Atlanta, Georgia, United States
Veterans Affairs Medical Center - Atlanta (Decatur), Decatur, Georgia, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois, United States
Veterans Affairs Medical Center - Lakeside Chicago, Chicago, Illinois, United States
CCOP - Central Illinois, Decatur, Illinois, United States
CCOP - Evanston, Evanston, Illinois, United States
CCOP - Illinois Oncology Research Association, Peoria, Illinois, United States
CCOP - Carle Cancer Center, Urbana, Illinois, United States
Indiana University Cancer Center, Indianapolis, Indiana, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush), Indianapolis, Indiana, United States
CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa, United States
CCOP - Iowa Oncology Research Association, Des Moines, Iowa, United States
Holden Comprehensive Cancer Center at The University of Iowa, Iowa City, Iowa, United States
MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana, United States
CCOP - Ochsner, New Orleans, Louisiana, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
CCOP - Ann Arbor Regional, Ann Arbor, Michigan, United States
CCOP - Kalamazoo, Kalamazoo, Michigan, United States
CCOP - Duluth, Duluth, Minnesota, United States
Veterans Affairs Medical Center - Minneapolis, Minneapolis, Minnesota, United States
University of Minnesota Cancer Center, Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States
CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska, United States
CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada, United States
Veterans Affairs Medical Center - East Orange, East Orange, New Jersey, United States
CCOP - Northern New Jersey, Hackensack, New Jersey, United States
Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Veterans Affairs Medical Center - Albany, Albany, New York, United States
Albert Einstein Comprehensive Cancer Center, Bronx, New York, United States
MBCCOP-Our Lady of Mercy Cancer Center, Bronx, New York, United States
Veterans Affairs Medical Center - Brooklyn, Brooklyn, New York, United States
Veterans Affairs Medical Center - New York, New York, New York, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York, New York, United States
CCOP - Merit Care Hospital, Fargo, North Dakota, United States
Ireland Cancer Center, Cleveland, Ohio, United States
Veterans Affairs Medical Center - Cleveland, Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
CCOP - Columbus, Columbus, Ohio, United States
CCOP - Toledo Community Hospital Oncology Program, Toledo, Ohio, United States
CCOP - Sooner State, Tulsa, Oklahoma, United States
Hahnemann University Hospital, Philadelphia, Pennsylvania, United States
University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, United States
Veterans Affairs Medical Center - Pittsburgh, Pittsburgh, Pennsylvania, United States
Guthrie Medical Center, Sayre, Pennsylvania, United States
CCOP - MainLine Health, Wynnewood, Pennsylvania, United States
CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota, United States
Veterans Affairs Medical Center - Nashville, Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
Veterans Affairs Medical Center - Madison, Madison, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, United States
CCOP - Marshfield Medical Research and Education Foundation, Marshfield, Wisconsin, United States
MBCCOP - San Juan, San Juan, , Puerto Rico
Veterans Affairs Medical Center - San Juan, San Juan, , Puerto Rico
Pretoria Academic Hospitals, Pretoria, , South Africa
Contact Details
Name: Morie A. Gertz, MD
Affiliation: Mayo Clinic
Role: STUDY_CHAIR
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