RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or 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	Procedure: biological response modifier therapy  Procedure: monoclonal antibody therapy  Procedure: antibody therapy  Drug: rituximab	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the objective response, time to treatment failure, and toxicity in patients with Waldenstrom's macroglobulinemia treated with rituximab. II. Correlate expression and changes in expression of CD20 on patient plasma cells and B-cells with clinical responses.

PROTOCOL OUTLINE: This is a multicenter study. Patients receive rituximab IV weekly for 4 weeks. Treatment may be repeated 2 months later in patients with stable disease, partial response, or complete response. Patients are followed every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 12-25 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Waldenstrom's macroglobulinemia; No more than 2 prior courses of therapy; No requirement for chemotherapy or steroid therapy for 90 days in previously untreated patients with slowly progressive disease

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: See Disease Characteristics; At least 30 days since prior chemotherapy
• Endocrine therapy: See Disease Characteristics; At least 30 days since prior steroid therapy
• Radiotherapy: At least 30 days since prior radiotherapy
• Surgery: Not specified

--Patient Characteristics--

• Age: Over 18
• Performance status: ECOG 0-2
• Life expectancy: At least 6 months
• Hematopoietic: Absolute neutrophil count greater than 1,000/mm3; Platelet count greater than 25,000/mm3
• Hepatic: Bilirubin less than 2.5 times upper limit of normal (ULN); SGOT less than 2.5 times ULN
• Renal: Creatinine less than 2.5 times ULN
• Other: Not pregnant or nursing; Fertile patients must use effective contraception during and for 3 months after study; No serious concurrent disease; No concurrent uncontrolled bacterial, fungal, or viral infection; No active second malignancy

California
      Cancer Center and Beckman Research Institute, City of Hope, Duarte,  California,  91010-3000,  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
Massachusetts
      Brigham and Women's Hospital, Boston,  Massachusetts,  02115,  United States
      Dana-Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States
      Massachusetts General Hospital Cancer Center, Boston,  Massachusetts,  02114,  United States
New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States
Canada, Alberta
      Cross Cancer Institute, Edmonton,  Alberta,  T6G 1Z2,  Canada

Study chairs or principal investigators

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

Study ID Numbers:  CDR0000067565; UCLA-9909016; NCI-G00-1709
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  March 7, 2000
ClinicalTrials.gov Identifier:  NCT00004889
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08