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A Phase I/II Trial of Combined Weekly Bortezomib (VELCADEĀ®) and Y-90-Ibritumomab Tiuxetan (Zevalin) in Patients With Relapsed or Refractory Follicular Lymphoma and Transformed Non-Hodgkin's Lymphoma


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

Thank you

Trial Information

A Phase I/II Trial of Combined Weekly Bortezomib (VELCADEĀ®) 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.

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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose and tolerability of bortezomib combined with Y-90-Ibritumomab Tiuxetan

Outcome Description:

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

Outcome 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

Safety Issue:

Yes

Principal Investigator

Jane Winter, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Northwestern University

Authority:

United States: Federal Government

Study ID:

NU 05H9

NCT ID:

NCT00372905

Start Date:

August 2006

Completion Date:

August 2015

Related Keywords:

  • Lymphoma
  • follicular lymphoma
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin

Name

Location

Emory University School of MedicineAtlanta, Georgia  30322
Northwestern UniversityChicago, Illinois  60611
University of Texas, San AntonioSan Antonio, Texas  78229-3900
David Geffen School of Medicine, UCLALos Angeles, California  90095
Northshore University HealthCareEvanston, Illinois  60201