A Phase I Study Evaluating Combined Zevalin (Ibritumomab Tiuxetan) and Valcade (Bortezomib) in Relapsed/Refractory Low-Grade or Follicular B-Cell and Mantle Cell Lymphoma
- Determine the maximum tolerated dose (MTD) of bortezomib in combination with rituximab
and yttrium Y 90 ibritumomab tiuxetan in patients with relapsed or refractory
low-grade, follicular B-cell, or mantle cell non-Hodgkin's lymphoma.
- Determine the dose-limiting toxicity of this regimen in these patients.
- Determine the response rate in patients treated with this regimen.
OUTLINE: This is a multicenter, open-label, nonrandomized, dose-escalation study of
Patients receive rituximab IV over 4 hours followed by indium In 111 ibritumomab tiuxetan IV
over 10 minutes on day 1 to assess biodistribution. Patients without altered biodistribution
receive rituximab IV over 4 hours followed by yttrium Y 90 ibritumomab tiuxetan IV over 10
minutes on day 8. Patients also receive bortezomib IV over 3-5 seconds on days 4, 8, 11, and
Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity. Additional patients may be treated at the
After completion of study treatment, patients are followed every 3 months for 18 months and
then every 6 months thereafter.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of bortezomib
Thomas C. Shea, MD
UNC Lineberger Comprehensive Cancer Center
United States: Federal Government
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill||Chapel Hill, North Carolina 27599-7570|
|Hackensack University Medical Center Cancer Center||Hackensack, New Jersey 07601|