Alemtuzumab in Treating Patients With Waldenstrom's Macroglobulinemia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase II Study of Campath-1H in Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia)

Conditions
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Lymphoma

Intervention / Treatment
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* Biological: alemtuzumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: alemtuzumab|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response |  |  | 
| Time to treatment failure |  |  | 
| Toxicity |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Waldenström macroglobulinemia