Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Waldenstrom's Macroglobulinemia

Study Overview
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Brief Summary
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RATIONALE: Monoclonal antibodies such as yttrium Y 90 ibritumomab tiuxetan and rituximab can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of yttrium Y 90 ibritumomab tiuxetan in treating patients who have Waldenstrom's macroglobulinemia.

Detailed Description
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OBJECTIVES: Determine the maximum tolerated dose of yttrium Y 90 ibritumomab tiuxetan in patients with Waldenstrom's macroglobulinemia. Determine, preliminarily, the response of patients treated with this drug. OUTLINE: This is a multicenter, dose-escalation study of yttrium Y 90 ibritumomab tiuxetan (IDEC-Y2B8). Patients receive rituximab IV and indium In 111 ibritumomab tiuxetan (IDEC-In2B8) IV over 10 minutes on day 1. Patients then undergo gamma camera scans within 2-24 hours. Approximately 7-14 days after IDEC-In2B8, patients receive rituximab IV and IDEC-Y2B8 IV over 10 minutes. Treatment with IDEC-Y2B8 may repeat every 12 weeks in the absence of unacceptable toxicity or the achievement of a maximum cumulative dose. Cohorts of 3-6 patients receive escalating doses of IDEC-Y2B8 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 3 months for 4 years. PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study.

Official Title
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Phase I Study of Zevalin (90Y-Ibritumomab Tiuxetan) in Waldenstrom's Macroglobulinemia (Lymphoplasmacytic Lymphoma)

Conditions
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Lymphoma

Intervention / Treatment
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* Biological: rituximab
* Radiation: yttrium Y 90 ibritumomab tiuxetan


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of Waldenstrom's macroglobulinemia confirmed by IgM gammopathy and bone marrow biopsy Presence of lymphoplasmacytic cells CD20+ plasma cell dyscrasia on the majority of malignant cells Bone marrow involvement of 20-50% by core needle biopsy of at least 1.5 cm in length Clinical indication for initiation of treatment, including 1 or more of the following characteristics: Symptoms associated with the disease (e.g., fatigue, asthenia, or painful adenopathy) Anemia IgM greater than 3 g/L Progression as indicated by a rate of IgM rise of more than 0.5 g over 6 months No myelodysplastic syndromes or profound hypocellularity of the bone marrow PATIENT CHARACTERISTICS: Age Over 18 Performance status WHO 0-2 Life expectancy More than 3 months Hematopoietic Absolute neutrophil count greater than 1,500/mm^3 Total B-lymphocyte count less than 5,000/mm^3 Platelet count greater than 100,000/mm^3 No hyperviscosity syndrome Hepatic Bilirubin no greater than 1.5 mg/dL Renal Not specified Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 1 year after study completion No uncontrolled CNS disease No serious nonmalignant disease that would preclude study participation No other concurrent active malignancy except controlled skin cancer or prostate cancer PRIOR CONCURRENT THERAPY: Biologic therapy More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF) More than 4 months since prior rituximab No prior radioimmunotherapy Chemotherapy No prior high-dose chemotherapy (unless patient has had prior back-up stem cell collections) More than 6 weeks since prior chemotherapy Endocrine therapy More than 4 weeks since prior corticosteroids Radiotherapy No 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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: rituximab|nan|
|Radiation: yttrium Y 90 ibritumomab tiuxetan|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

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