Radiolabeled Monoclonal Antibody in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Recruitment status was Active, not recruiting
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.
Radiation: yttrium Y 90 ibritumomab tiuxetan
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I, Multicenter, Open Label, Dose Escalation Of 90Y-Zevalin Radioimmunotherapy Using A Modified Treatment Regimen For Relapsed Or Refractory CD20+ B-Cell (Follicular/Transformed) Non-Hodgkin's Lymphoma|
|Study Start Date:||February 2002|
- 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.
|United States, Alabama|
|Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham|
|Birmingham, Alabama, United States, 35294|
|United States, California|
|Stanford Comprehensive Cancer Center - Stanford|
|Stanford, California, United States, 94305|
|United States, Minnesota|
|Mayo Clinic Cancer Center|
|Rochester, Minnesota, United States, 55905|
|Study Chair:||Andres Forero-Torres, MD, CSU||University of Alabama at Birmingham|