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
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.
Interventional
Primary Purpose: Treatment
Andres Forero-Torres, MD, CSU
Study Chair
University of Alabama at Birmingham
United States: Federal Government
CDR0000069282
NCT00033423
February 2002
Name | Location |
---|---|
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 |