RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different way to stop cancer cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of rituximab plus fludarabine in treating patients who have Waldenstrom's macroglobulinemia.

Condition	Treatment or Intervention	Phase
Waldenstrom's Macroglobulinemia	Drug: fludarabine  Drug: rituximab  Procedure: antibody therapy  Procedure: biological response modifier therapy  Procedure: chemotherapy  Procedure: monoclonal antibody therapy	Phase II

Further Study Details: 

OBJECTIVES:

• Determine the objective response and time to treatment failure in patients with Waldenstrom's macroglobulinemia treated with rituximab and fludarabine.
• Determine the toxicity of this regimen in these patients.
• Determine if molecular remissions are achievable in patients attaining a clinical complete response when treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive rituximab IV over 3-6 hours once weekly on weeks 1-4, 17, 18, 30, and 31 and fludarabine IV over 10-30 minutes once daily for 5 days on weeks 5, 9, 13, 19, 23, and 27.

Patients are followed at least every 2 months for 2 years.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of Waldenstrom's macroglobulinemia
• CD20 positive by bone marrow immunohistochemistry or flow cytometry
• Presence of monoclonal paraprotein
• IgM level at least 2 times upper limit of normal (ULN)

PATIENT CHARACTERISTICS: Age:

• Over 18

Performance status:

• ECOG 0-2

Life expectancy:

• At least 6 months

Hematopoietic:

• Absolute neutrophil count greater than 1,000/mm^3
• Platelet count greater than 25,000/mm^3

Hepatic:

• Bilirubin less than 2.5 times ULN
• SGOT less than 2.5 times ULN

Renal:

• Creatinine less than 2.5 mg/dL

Other:

• Not pregnant or nursing
• Fertile patients must use effective contraception during and for 6 months after study
• No serious comorbid disease
• No uncontrolled bacterial, fungal, or viral infection
• No other active malignancy

PRIOR CONCURRENT THERAPY: Biologic therapy:

• No prior rituximab
• No prior nucleoside analogue therapy

Chemotherapy:

• At least 30 days since prior chemotherapy

Endocrine therapy:

• At least 30 days since prior steroid therapy
• No concurrent corticosteroids

Radiotherapy:

• At least 30 days since prior radiotherapy

Surgery:

• Not specified

Other:

• No more than 2 prior courses of therapy

Arizona
      Arizona Cancer Center, Tucson,  Arizona,  85724,  United States
California
      Cedars-Sinai Medical Center, Los Angeles,  California,  90048,  United States
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States
District of Columbia
      Walter Reed Army Medical Center, Washington,  District of Columbia,  20307-5000,  United States
Illinois
      Rush-Presbyterian-St. Luke's Medical Center, Chicago,  Illinois,  60612,  United States
Iowa
      Holden Comprehensive Cancer Center, Iowa City,  Iowa,  52242-1009,  United States
Maryland
      Marlene and Stewart Greenebaum Cancer Center, University of Maryland, Baltimore,  Maryland,  21201,  United States
Massachusetts
      Dana-Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States
      Massachusetts General Hospital Cancer Center, Boston,  Massachusetts,  02114,  United States
      Tuft-New England Medical Center, Boston,  Massachusetts,  02111,  United States
New York
      Long Island Jewish Medical Center, New Hyde Park,  New York,  11040,  United States
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States
Ohio
      Barrett Cancer Center, Cincinnati,  Ohio,  45267-0502,  United States
      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44195,  United States
Canada, Alberta
      Cross Cancer Institute, Edmonton,  Alberta,  T6G 1Z2,  Canada
Canada, Ontario
      Chedoke-McMaster Hospitals, Hamilton,  Ontario,  L8N 3Z5,  Canada
Sweden
      Huddinge University Hospital, Stockholm,  SE-141 86,  Sweden
United Kingdom, England
      Saint Bartholomew's Hospital, London,  England,  EC1A 7BE,  United Kingdom

Study chairs or principal investigators

Christos E. Emmanouilides, MD,  Study Chair,  Jonsson Comprehensive Cancer Center   

Study ID Numbers:  CDR0000068714; UCLA-010106301; NCI-G01-1960
Record last reviewed:  October 2003
Last Updated:  October 13, 2004
Record first received:  July 11, 2001
ClinicalTrials.gov Identifier:  NCT00020800
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08