RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.
OBJECTIVES: * Determine the maximum tolerated dose of yttrium Y 90 ibritumomab tiuxetan when administered in combination with rituximab in patients with relapsed or refractory low-grade, follicular, or transformed CD20-positive B-cell non-Hodgkin's lymphoma (NHL). * Determine the toxicity of different doses of yttrium Y 90 ibritumomab tiuxetan in patients treated with this regimen. * Determine the frequency of reversal of bone marrow involvement with NHL in patients treated with this regimen. * Determine the antitumor response in patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of yttrium Y 90 ibritumomab tiuxetan. Patients receive rituximab IV once weekly on weeks 1-4. After 4 doses of rituximab, patients without bone marrow involvement and cellularity greater than 50% expected receive rituximab IV once weekly on weeks 6 and 7 and yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes with the final dose of rituximab (day 43). Cohorts of 5-6 patients receive escalating dose of yttrium Y 90 ibritumomab tiuxetan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 4 of 5 or 3 of 6 patients experience dose-limiting toxicity. Patients are followed at 6 and 12 weeks, every 2-3 months for 2 years, and then every 6 months for 2 years. PROJECTED ACCRUAL: Approximately 6-30 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham
Birmingham, Alabama, United States
Stanford Comprehensive Cancer Center - Stanford
Stanford, California, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Determine the maximum tolerated dose of yttrium Y 90 ibritumomab tiuxetan when administered in combination with rituximab in patients with relapsed or refractory low-grade, follicular, or transformed CD20-positive B-cell non-Hodgkin's lymphoma (NHL).
Time frame: baseline through 4 years
Determine the toxicity of different doses of yttrium Y 90 ibritumomab tiuxetan in patients treated with this regimen
Time frame: baseline through 4 years
Determine the frequency of reversal of bone marrow involvement with NHL in patients treated with this regimen.
Time frame: baseline through 4 years
Determine the antitumor response in patients treated with this regimen.
Time frame: baseline through 4 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.