Lymphoma
Conditions
Keywords
Waldenström macroglobulinemia
Brief 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.
Detailed description
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.
Interventions
BIOLOGICALrituximab
RADIATIONyttrium Y 90 ibritumomab tiuxetan
Sponsors
National Cancer Institute (NCI)
Jonsson Comprehensive Cancer Center
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Countries
United States
Outcome results
None listed