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
NCT ID: NCT00334438
Last Updated: 2016-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2006-07-31
2011-10-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Zevalin + Velcade Single Arm Study
Zevalin (Ibritumomab Tiuxetan) and Velcade (Bortezomib)
rituximab
250mg/m2, IV, Days 1 and 8
bortezomib
dose escalation 1.0, 1.3, or 1.5, IVP; Days 4, 8, 11, 15
yttrium Y 90 ibritumomab tiuxetan
Dose dependant upon platelet count (0.4mCi/kg) not to exceed 32mCi; Day 8
Indium 111 ibritumomab tiuxetan
5cmCi; IV day 1
Interventions
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rituximab
250mg/m2, IV, Days 1 and 8
bortezomib
dose escalation 1.0, 1.3, or 1.5, IVP; Days 4, 8, 11, 15
yttrium Y 90 ibritumomab tiuxetan
Dose dependant upon platelet count (0.4mCi/kg) not to exceed 32mCi; Day 8
Indium 111 ibritumomab tiuxetan
5cmCi; IV day 1
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed low-grade, follicular B-cell, or mantle cell non-Hodgkin's lymphoma
* Bone marrow biopsy required for pretreatment evaluation
* Unilateral bone marrow biopsy allowed
* Core biopsies allowed if they contain adequate tissue for primary diagnosis and immunophenotyping
* Relapsed or refractory disease as defined by disease progression after initial complete response (CR) or failure to achieve CR
* No bone marrow involvement ≥ 25% within the past 30 days
* No pleural effusion or significant ascites
* No active CNS involvement
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Life expectancy ≥ 3 months
* Platelet count ≥ 100,000/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3
* AST ≤ 2.5 times upper limit of normal (ULN)
* Total bilirubin ≤ 2.5 times ULN
* Creatinine clearance ≥ 50 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Hepatitis B surface antigen negative
* No current infection with hepatitis B virus
* No HIV positivity
* No neuropathy or neuropathic pain ≥ grade 2
* No history of allergic reaction to boron or mannitol
* No active serious infection or medical or psychiatric illness that would preclude study therapy
* No other malignancy within the past 5 years except for the following:
* Basal cell or squamous cell carcinoma of the skin that has been completely resected
* In situ malignancy that has been completely resected
* T1-T2a, N0, M0 prostate cancer treated with a prostatectomy or radiotherapy within the past 2 years with an undetectable PSA level
* No other condition, including any of the following:
* Myocardial infarction within the past 6 months
* New York Heart Association class III-IV heart failure
* Uncontrolled angina
* Severe uncontrolled ventricular arrhythmias
* Electrocardiographic evidence of acute ischemia or active conduction system abnormalities
PRIOR CONCURRENT THERAPY:
* Recovered from all prior therapy
* More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C), radiotherapy, or surgical resection of malignancy
* No limitations on the number of prior therapies
* More than 4 weeks since prior major surgery
* More than 14 days since prior filgrastim (G-CSF) or sargramostim (GM-CSF)
* More than 14 days since prior and no other concurrent investigational agents
* Concurrent participation in a nontreatment study allowed
* No prior radioimmunotherapy
18 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
UNC Lineberger Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Thomas C. Shea, MD
Role: PRINCIPAL_INVESTIGATOR
UNC Lineberger Comprehensive Cancer Center
Locations
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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
Countries
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Other Identifiers
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CDR0000550130
Identifier Type: OTHER
Identifier Source: secondary_id
LCCC 0525
Identifier Type: -
Identifier Source: org_study_id