Status:
COMPLETED
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
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lymphoma
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
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...
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, ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00334438
Start Date
July 1 2006
End Date
October 1 2011
Last Update
December 23 2016
Active Locations (2)
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1
Hackensack University Medical Center Cancer Center
Hackensack, New Jersey, United States, 07601
2
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295