Overview

This trial is active, not recruiting.

Condition lymphoma
Treatments rituximab, bortezomib, ibritumomab tiuxetan
Phase phase 1/phase 2
Targets CD20, proteasome
Sponsor Northwestern University
Collaborator Robert H. Lurie Cancer Center
Start date August 2006
End date August 2016
Trial size 24 participants
Trial identifier NCT00372905, NU 05H9, STU00004871

Summary

Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Giving bortezomib together with rituximab and yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells.

This phase I/II trial is studying the side effects and best dose of bortezomib when given together with rituximab and yttrium Y 90 ibritumomab tiuxetan and to see how well they work in treating patients with relapsed or refractory follicular non-Hodgkin's lymphoma.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Induction therapy will last 28 days. Bortezomib will be given on days 1, 8, 15, and 22. Rituximab will be given on days 8 and 15 along with 111-indium-ibritumomab tiuxetan. During consolidation therapy, Bortezomib will be given intravenously on days 1, 8, and 15 of each cycle for a maximum of 3 cycles. Rituximab or Y-90-ibritumomab tiuxetan will not be given during consolidation therapy.
rituximab Rituxan, IDEC-C2B8
Induction therapy will last 28 days. Bortezomib will be given on days 1, 8, 15, and 22. Rituximab will be given on days 8 and 15 along with 111-indium-ibritumomab tiuxetan. During consolidation therapy, Bortezomib will be given intravenously on days 1, 8, and 15 of each cycle for a maximum of 3 cycles. Rituximab or Y-90-ibritumomab tiuxetan will not be given during consolidation therapy.
bortezomib Velcade
Induction therapy will last 28 days. Bortezomib will be given on days 1, 8, 15, and 22. Rituximab will be given on days 8 and 15 along with 111-indium-ibritumomab tiuxetan. During consolidation therapy, Bortezomib will be given intravenously on days 1, 8, and 15 of each cycle for a maximum of 3 cycles. Rituximab or Y-90-ibritumomab tiuxetan will not be given during consolidation therapy.
ibritumomab tiuxetan 111-indium-ibritumomab tiuxetan, Y-90-ibritumomab tiuxetan
Induction therapy will last 28 days. Bortezomib will be given on days 1, 8, 15, and 22. Rituximab will be given on days 8 and 15 along with 111-indium-ibritumomab tiuxetan. During consolidation therapy, Bortezomib will be given intravenously on days 1, 8, and 15 of each cycle for a maximum of 3 cycles. Rituximab or Y-90-ibritumomab tiuxetan will not be given during consolidation therapy.

Primary Outcomes

Measure
Maximum tolerated dose and tolerability of bortezomib combined with Y-90-Ibritumomab Tiuxetan
time frame: 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

Secondary Outcomes

Measure
toxicity and efficacy of bortezomib combined with Y-90-ibritumomab tiuxetan
time frame: 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

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Histologically confirmed follicular lymphoma - CD20+ at time of diagnosis or subsequently - More than 4 weeks since prior rituximab - More than 3 weeks since prior anticancer therapy (6 weeks for nitrosourea or mitomycin C) - More than 4 weeks since prior major surgery - More than 2 weeks since prior investigational drugs Exclusion Criteria: - AIDS-related lymphoma - History or evidence of CNS involvement - Pregnant or nursing - known HIV positivity - serious medical or psychiatric illness that would preclude study participation - myocardial infarction within the past 6 months - congestive heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or ECG evidence of acute ischemia or active conduction system abnormalities - known hypersensitivity to rituximab, bortezomib, boron, or mannitol - prior autologous or allogeneic stem cell transplantation - prior radioimmunoconjugate therapy or prior exposure to murine antibodies - prior external-beam irradiation to > 25% of active bone marrow

Additional Information

Official title 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
Principal investigator Jane Winter, MD
Description This is a phase I, dose-escalation study of bortezomib followed by a phase II study. Phase I: - 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Northwestern University.