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
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|ClinicalTrials.gov Identifier: NCT00334438|
Recruitment Status : Completed
First Posted : June 7, 2006
Last Update Posted : December 23, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: rituximab Drug: bortezomib Radiation: yttrium Y 90 ibritumomab tiuxetan Radiation: Indium 111 ibritumomab tiuxetan||Phase 1|
- 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 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||July 2006|
|Actual Primary Completion Date :||October 2008|
|Actual Study Completion Date :||October 2011|
Zevalin + Velcade Single Arm Study
Zevalin (Ibritumomab Tiuxetan) and Velcade (Bortezomib)
250mg/m2, IV, Days 1 and 8
Other Name: Rituxan
dose escalation 1.0, 1.3, or 1.5, IVP; Days 4, 8, 11, 15
Other Name: Velcade
Radiation: yttrium Y 90 ibritumomab tiuxetan
Dose dependant upon platelet count (0.4mCi/kg) not to exceed 32mCi; Day 8
Radiation: Indium 111 ibritumomab tiuxetan
5cmCi; IV day 1
- Maximum tolerated dose of bortezomib [ Time Frame: 2 years ]
- Dose-limiting toxicity [ Time Frame: 8 weeks ]
- Response rate [ Time Frame: 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00334438
|United States, New Jersey|
|Hackensack University Medical Center Cancer Center|
|Hackensack, New Jersey, United States, 07601|
|United States, North Carolina|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599-7295|
|Principal Investigator:||Thomas C. Shea, MD||UNC Lineberger Comprehensive Cancer Center|