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.

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

Further Study Details: 

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.

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

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of Waldenstrom's macroglobulinemia (lymphoplasmacytic lymphoma)
• Immunoglobulin (Ig) M, IgG, and IgA paraprotein
• Measurable monoclonal paraprotein
• Failed at least 1 prior first-line therapy (alkylator agent, nucleoside analogue, or rituximab)
• CD52-positive tumor determined by either bone marrow immunohistochemistry or flow cytometry

PATIENT CHARACTERISTICS: Age

• Over 18

Performance status

• ECOG 0-2

Life expectancy

• At least 6 months

Hematopoietic

• Absolute neutrophil count ≥ 500/mm^3
• Platelet count ≥ 25,000/mm^3

Hepatic

• SGOT ≤ 2.5 times upper limit of normal (ULN)
• Bilirubin ≤ 2.5 times ULN

Renal

• Creatinine ≤ 2.5 mg/dL (> 2.5 mg/dL allowed if due to disease)

Other

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

PRIOR CONCURRENT THERAPY: Biologic therapy

• See Disease Characteristics
• No prior alemtuzumab
• More than 3 months since other prior monoclonal antibody therapy

Chemotherapy

• See Disease Characteristics
• More than 21 days since prior chemotherapy

Endocrine therapy

• More than 21 days since prior steroid therapy

Radiotherapy

• More than 21 days since prior radiotherapy

Surgery

• Not specified

California
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1678,  United States; Recruiting
Colorado
      Rocky Mountain Cancer Centers - Denver Midtown, Denver,  Colorado,  80218,  United States; Recruiting
Illinois
      Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago,  Illinois,  60611-3013,  United States; Recruiting
Maryland
      Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore,  Maryland,  21201,  United States; Recruiting
Massachusetts
      Beth Israel Deaconess Medical Center, Boston,  Massachusetts,  02215,  United States; Recruiting
      Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States; Recruiting
      Massachusetts General Hospital Cancer Center, Boston,  Massachusetts,  02114,  United States; Recruiting
New York
      Herbert Irving Comprehensive Cancer Center at Columbia University, New York,  New York,  10032,  United States; Recruiting
      Long Island Jewish Medical Center, New Hyde Park,  New York,  11040,  United States; Recruiting
Ohio
      Charles M. Barrett Cancer Center at University Hospital, Cincinnati,  Ohio,  45267-0502,  United States; Recruiting
      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44195,  United States; Recruiting
Australia, Victoria
      Peter MacCallum Cancer Centre, East Melbourne,  Victoria,  3002,  Australia; Recruiting
Canada, Ontario
      McMaster Children's Hospital at Hamilton Health Sciences, Hamilton,  Ontario,  ON L8N 3Z5,  Canada; Recruiting
      Princess Margaret Hospital, Toronto,  Ontario,  M5G 2C1,  Canada; Recruiting
France
      Centre Hospitalier Lens, Lens,  Cedex 62307,  France; Recruiting
United Kingdom, England
      Saint Bartholomew's Hospital, London,  England,  EC1A 7BE,  United Kingdom; Recruiting

Study chairs or principal investigators

Jennifer Gansert, MD, PhD,  Study Chair,  Jonsson Comprehensive Cancer Center   

Study ID Numbers:  CDR0000358811; UCLA-0309058
Record last reviewed:  October 2004
Last Updated:  April 4, 2005
Record first received:  April 7, 2004
ClinicalTrials.gov Identifier:  NCT00081068
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08