yttrium y 90 ibritumomab tiuxetan in treating patients with waldenstrom's macroglobulinemia

Conditions: Lymphoma

Summary: 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.

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.

Eligibility criteria:
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

Keywords: waldenström macroglobulinemia