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.

Condition	Treatment or Intervention	Phase
Waldenstrom's Macroglobulinemia	Drug: rituximab	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Waldenstrom's macroglobulinemia confirmed by the following: Bone marrow lymphoplasmacytosis with: Greater than 10% lymphoplasmacytic cells OR Aggregates, sheets, lymphocytes, plasma cells, or lymphoplasmacytic cells on bone marrow biopsy AND Measurable disease defined as quantitative; IgM monoclonal protein greater than 1,000 mg/dL; Bone marrow lymphoplasmacytosis and beta-2 microglobulin in the serum are not considered measurable
• Impaired bone marrow function due to infiltration by lymphoplasmacytic lymphoma; Hemoglobin less than 11 g/dL OR Serum viscosity level relative to water greater than 4.0
• Symptomatic with clinically significant anemia (less than 11 g/dL), bulky lymphadenopathy that is symptomatic, or symptoms attributable to hyperviscosity (e.g., nose bleeding, gingival bleeding, retinal hemorrhage)

--Prior/Concurrent Therapy--

• No more than 2 prior regimens allowed; Prior tandem transplant considered 2 prior regimens; Chemotherapy prior to bone marrow transplantation as part of induction considered 1 prior regimen Retreatment with same regimen (e.g., repeated alkylating agents) considered 1 prior regimen
• Biologic therapy: No prior anti-CD20 therapy; At least 1 month since prior epoetin alfa; No concurrent epoetin alfa for 2 months after registration
• Chemotherapy: At least 28 days since prior alkylating agents; At least 28 days since prior purine nucleoside analogues
• Endocrine therapy: At least 28 days since prior corticosteroid therapy
• Radiotherapy: At least 4 weeks since prior radiotherapy
• Surgery: Not specified
• Other: Concurrent digoxin to control atrial fibrillation allowed

--Patient Characteristics--

• Age: 18 and over
• Performance status: ECOG 0-3
• Life expectancy: Not specified
• Hematopoietic: See Disease Characteristics
• Hepatic: SGOT less than 3 times upper limit of normal; Bilirubin less than 2.0 mg/dL
• Renal: Creatinine no greater than 3.0 mg/dL
• Cardiovascular: No myocardial infarction within past 6 months; No significant arrhythmia within past 3 months; Hypertension allowed provided controlled with medication
• Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; Concurrent reversible complications (e.g., hyperuricemia, hyperviscosity) allowed provided therapy for complication initiated and complications subsiding; Other prior malignancies allowed provided curatively treated and currently disease free

Arizona
      CCOP - Scottsdale Oncology Program, Scottsdale,  Arizona,  85259-5404,  United States
California
      Cancer Center and Beckman Research Institute, City of Hope, Duarte,  California,  91010-3000,  United States
      Stanford University Medical Center, Stanford,  California,  94305-5408,  United States
      Veterans Affairs Medical Center - Palo Alto, Palo Alto,  California,  94304,  United States
Colorado
      CCOP - Colorado Cancer Research Program, Inc., Denver,  Colorado,  80209-5031,  United States
Delaware
      CCOP - Christiana Care Health Services, Wilmington,  Delaware,  19899,  United States
District of Columbia
      Walter Reed Army Medical Center, Washington,  District of Columbia,  20307-5000,  United States
Florida
      H. Lee Moffitt Cancer Center and Research Institute, Tampa,  Florida,  33612-9497,  United States
      Veterans Affairs Medical Center - Gainsville, Gainesville,  Florida,  32608-1197,  United States
      Veterans Affairs Medical Center - Tampa (Haley), Tampa,  Florida,  33612,  United States
Georgia
      Emory University Hospital - Atlanta, Atlanta,  Georgia,  30322,  United States
      Veterans Affairs Medical Center - Atlanta (Decatur), Decatur,  Georgia,  30033,  United States
Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States
      CCOP - Central Illinois, Decatur,  Illinois,  62526,  United States
      CCOP - Evanston, Evanston,  Illinois,  60201,  United States
      CCOP - Illinois Oncology Research Association, Peoria,  Illinois,  61602,  United States
      Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago,  Illinois,  60611-3013,  United States
      Veterans Affairs Medical Center - Lakeside Chicago, Chicago,  Illinois,  60611,  United States
Indiana
      Indiana University Cancer Center, Indianapolis,  Indiana,  46202-5289,  United States
      Veterans Affairs Medical Center - Indianapolis (Roudebush), Indianapolis,  Indiana,  46202,  United States
Iowa
      CCOP - Cedar Rapids Oncology Project, Cedar Rapids,  Iowa,  52403-1206,  United States
      CCOP - Iowa Oncology Research Association, Des Moines,  Iowa,  50309-1016,  United States
      Holden Comprehensive Cancer Center at The University of Iowa, Iowa City,  Iowa,  52242-1009,  United States
Louisiana
      CCOP - Ochsner, New Orleans,  Louisiana,  70121,  United States
      MBCCOP - LSU Health Sciences Center, New Orleans,  Louisiana,  70112,  United States
Maryland
      Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore,  Maryland,  21231-2410,  United States
Massachusetts
      Beth Israel Deaconess Medical Center, Boston,  Massachusetts,  02215,  United States
Michigan
      CCOP - Ann Arbor Regional, Ann Arbor,  Michigan,  48106,  United States
      CCOP - Kalamazoo, Kalamazoo,  Michigan,  49007-3731,  United States
Minnesota
      CCOP - Duluth, Duluth,  Minnesota,  55805,  United States
      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States
      University of Minnesota Cancer Center, Minneapolis,  Minnesota,  55455,  United States
      Veterans Affairs Medical Center - Minneapolis, Minneapolis,  Minnesota,  55417,  United States
Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68131,  United States
Nevada
      CCOP - Southern Nevada Cancer Research Foundation, Las Vegas,  Nevada,  89106,  United States
New Jersey
      Cancer Institute of New Jersey, New Brunswick,  New Jersey,  08901,  United States
      CCOP - Northern New Jersey, Hackensack,  New Jersey,  07601,  United States
      Veterans Affairs Medical Center - East Orange, East Orange,  New Jersey,  07018-1095,  United States
New York
      Albert Einstein Comprehensive Cancer Center, Bronx,  New York,  10461,  United States
      MBCCOP-Our Lady of Mercy Cancer Center, Bronx,  New York,  10466,  United States
      NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York,  New York,  10016,  United States
      Veterans Affairs Medical Center - Albany, Albany,  New York,  12208,  United States
      Veterans Affairs Medical Center - Brooklyn, Brooklyn,  New York,  11209,  United States
      Veterans Affairs Medical Center - New York, New York,  New York,  10010,  United States
North Dakota
      CCOP - Merit Care Hospital, Fargo,  North Dakota,  58122,  United States
Ohio
      CCOP - Columbus, Columbus,  Ohio,  43206,  United States
      CCOP - Toledo Community Hospital Oncology Program, Toledo,  Ohio,  43623-3456,  United States
      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44195,  United States
      Ireland Cancer Center, Cleveland,  Ohio,  44106-5065,  United States
      Veterans Affairs Medical Center - Cleveland, Cleveland,  Ohio,  44106,  United States
Oklahoma
      CCOP - Sooner State, Tulsa,  Oklahoma,  74136,  United States
Pennsylvania
      CCOP - MainLine Health, Wynnewood,  Pennsylvania,  19096,  United States
      Fox Chase Cancer Center, Philadelphia,  Pennsylvania,  19111,  United States
      Guthrie Medical Center, Sayre,  Pennsylvania,  18840,  United States
      Hahnemann University Hospital, Philadelphia,  Pennsylvania,  19102-1192,  United States
      Kimmel Cancer Center of Thomas Jefferson University - Philadelphia, Philadelphia,  Pennsylvania,  19107-5541,  United States
      University of Pennsylvania Cancer Center, Philadelphia,  Pennsylvania,  19104-4283,  United States
      University of Pittsburgh Cancer Institute, Pittsburgh,  Pennsylvania,  15213-3489,  United States
      Veterans Affairs Medical Center - Pittsburgh, Pittsburgh,  Pennsylvania,  15240,  United States
South Dakota
      CCOP - Sioux Community Cancer Consortium, Sioux Falls,  South Dakota,  57105-1080,  United States
Tennessee
      Vanderbilt-Ingram Cancer Center, Nashville,  Tennessee,  37232-6838,  United States
      Veterans Affairs Medical Center - Nashville, Nashville,  Tennessee,  37212,  United States
Wisconsin
      CCOP - Marshfield Medical Research and Education Foundation, Marshfield,  Wisconsin,  54449,  United States
      University of Wisconsin Comprehensive Cancer Center, Madison,  Wisconsin,  53792-6164,  United States
      Veterans Affairs Medical Center - Madison, Madison,  Wisconsin,  53705,  United States
Puerto Rico
      MBCCOP - San Juan, San Juan,  00927-5800,  Puerto Rico
      Veterans Affairs Medical Center - San Juan, San Juan,  00927-5800,  Puerto Rico
South Africa
      Pretoria Academic Hospitals, Pretoria,  0001,  South Africa

Study chairs or principal investigators

Morie Abraham Gertz,  Study Chair,  Eastern Cooperative Oncology Group   

Study ID Numbers:  CDR0000067738; E-3A98
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  May 2, 2000
ClinicalTrials.gov Identifier:  NCT00005609
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08