A Phase I/II Trial of Combined Weekly Bortezomib (VELCADE®) and Y-90-Ibritumomab Tiuxetan (Zevalin) in Patients With Relapsed or Refractory Follicular Lymphoma and Transformed Non-Hodgkin's Lymphoma
This is a phase I, dose-escalation study of bortezomib followed by a phase II study.
- Induction therapy: Patients receive bortezomib IV over 3-5 seconds on days 1, 8, 15, and
22, rituximab IV on days 8 and 15, and yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes
on day 15.
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 6
patients experience dose-limiting toxicity.
- Consolidation therapy: Beginning 6-7 weeks after completing induction therapy, patients
receive bortezomib IV over 3-5 seconds on days 1, 8, and 15. Treatment repeats every 28 days
for 3 courses in the absence of disease progression or unacceptable toxicity.
Phase II: Patients receive induction therapy and consolidation therapy as in phase I, with
bortezomib administered at the MTD determined in phase I.
After completion of study treatment, patients are followed every 3 months for 1 year, every
6 months for 1 year, and then annually thereafter.
A total of 24 patients will be accrued for this study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose and tolerability of bortezomib combined with Y-90-Ibritumomab Tiuxetan
To determine the maximum tolerated dose (up to 1.6 mg/m2 ) of bortezomib combined with Y-90-Ibritumomab Tiuxetan in patients with relapsed and refractory follicular NHL and the tolerability of weekly bortezomib (three weeks out of four) following treatment with Y-90-Ibritumomab tiuxetan
Baseline, days 1, 8, 15, 22 of induction, days 36 and 50 of recovery, days 1, 8, 15 of consolidation cycle, 4 weeks after completion of treatment, every 3 mo for one year, every 6 mo for second year, once a year thereafter
Jane Winter, MD
United States: Federal Government
|Emory University School of Medicine||Atlanta, Georgia 30322|
|Northwestern University||Chicago, Illinois 60611|
|University of Texas, San Antonio||San Antonio, Texas 78229-3900|
|David Geffen School of Medicine, UCLA||Los Angeles, California 90095|
|Northshore University HealthCare||Evanston, Illinois 60201|