Phase I Study of Zevalin (90Y-Ibritumomab Tiuxetan) in Waldenstrom's Macroglobulinemia (Lymphoplasmacytic Lymphoma)
- 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
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.
Primary Purpose: Treatment
Christos E. Emmanouilides, MD
Jonsson Comprehensive Cancer Center
United States: Food and Drug Administration
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute||Boston, Massachusetts 02115|