Bortezomib, Rituximab, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Relapsed or Refractory Low-Grade, Follicular, or Mantle Cell Non-Hodgkin's Lymphoma
- Conditions
- Lymphoma
- Interventions
- Biological: rituximabRadiation: yttrium Y 90 ibritumomab tiuxetanRadiation: Indium 111 ibritumomab tiuxetan
- Registration Number
- NCT00334438
- Lead Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Brief Summary
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, and radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, 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 without harming normal cells. Giving bortezomib together with rituximab and yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when given together with rituximab and yttrium Y 90 ibritumomab tiuxetan in treating patients with relapsed or refractory low-grade, follicular, or mantle cell non-Hodgkin's lymphoma.
- Detailed Description
OBJECTIVES:
Primary
* 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.
Secondary
* Determine the response rate in patients treated with this regimen.
OUTLINE: This is a multicenter, open-label, nonrandomized, dose-escalation study of bortezomib.
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 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 3 or 2 of 6 patients experience dose-limiting toxicity. Additional patients may be treated at the MTD.
After completion of study treatment, patients are followed every 3 months for 18 months and then every 6 months thereafter.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Zevalin + Velcade Single Arm Study bortezomib Zevalin (Ibritumomab Tiuxetan) and Velcade (Bortezomib) Zevalin + Velcade Single Arm Study Indium 111 ibritumomab tiuxetan Zevalin (Ibritumomab Tiuxetan) and Velcade (Bortezomib) Zevalin + Velcade Single Arm Study rituximab Zevalin (Ibritumomab Tiuxetan) and Velcade (Bortezomib) Zevalin + Velcade Single Arm Study yttrium Y 90 ibritumomab tiuxetan Zevalin (Ibritumomab Tiuxetan) and Velcade (Bortezomib)
- Primary Outcome Measures
Name Time Method Maximum tolerated dose of bortezomib 2 years Dose-limiting toxicity 8 weeks
- Secondary Outcome Measures
Name Time Method Response rate 5 years
Trial Locations
- Locations (2)
Hackensack University Medical Center Cancer Center
🇺🇸Hackensack, New Jersey, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States