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
- 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
- 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.
Primary Purpose: Treatment
Andres Forero-Torres, MD, CSU
University of Alabama at Birmingham
United States: Federal Government
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|Stanford Comprehensive Cancer Center - Stanford||Stanford, California 94305|
|Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham||Birmingham, Alabama 35294|