Bortezomib and Rituximab in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma
Lymphoma
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, splenic marginal zone lymphoma, recurrent adult diffuse small cleaved cell lymphoma, nodal marginal zone B-cell lymphoma, Waldenstrom's macroglobulinemia
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed B-cell non-Hodgkin's lymphoma (NHL) including the following subtypes: B-cell small lymphocytic lymphoma Marginal zone lymphoma (extranodal, nodal, or splenic) Grade 1-3 follicular lymphoma Mantle cell lymphoma Waldenstrom's macroglobulinemia Bidimensionally measurable disease by CT scan with ≥ 1 lesion measuring > 1.5 cm in a single dimension Relapsed or refractory disease after prior antineoplastic therapy, meeting 1 of the following criteria: No response to prior treatment Relapsed disease after prior therapy Confirmed CD20-positive disease by immunohistochemistry on biopsy specimen Prior transformation allowed provided there is no evidence of aggressive histology on recent biopsy No chronic lymphocytic lymphoma with absolute lymphocyte count > 5,000/mm³ No CNS involvement PATIENT CHARACTERISTICS: ECOG performance status 0-2 Absolute neutrophil count ≥ 1,500/mm^3 (≥ 1,000/mm³ if due to extensive bone marrow involvement with NHL or splenomegaly) Absolute lymphocyte count ≤ 5,000/mm³ (except mantle cell lymphoma with a leukemic phase) Platelet count ≥ 50,000/mm^3 Bilirubin ≤ 2.0 mg/dL AST and ALT ≤ 2.5 times upper limit of normal (ULN) (4 times ULN if liver involvement with NHL) Creatinine ≤ 2.0 mg/dL Not pregnant or nursing Negative pregnancy test Fertile male and female patients must use effective contraception during study No serious nonmalignant disease No active infection No peripheral neuropathy ≥ grade 2 within past 14 days No myocardial infarction within the past 6 months No New York Heart Association class III or IV heart failure No uncontrolled angina pectoris No severe uncontrolled ventricular arrhythmias No EKG evidence of acute ischemia or active conduction system abnormalities Any EKG abnormality must be documented as not medically relevant No hypersensitivity to bortezomib, boron, or mannitol No known anaphylaxis or immunoglobulin E-mediated hypersensitivity to murine proteins or any component of rituximab (including polysorbate 80 and sodium citrate dehydrate) No known infection or exposure to HIV No serious psychiatric or medical illness that would preclude study participation No active hepatitis B infection No other primary malignancy requiring active treatment More than 4 weeks since prior significant traumatic injury PRIOR CONCURRENT THERAPY: At least 3 weeks since prior and no concurrent radiotherapy More than 4 weeks since prior major surgery or open biopsy Other diagnostic surgery allowed More than 4 weeks since prior cytotoxic chemotherapy (6 weeks for nitrosoureas) At least 3 months since prior unconjugated monoclonal antibody therapy At least 10 weeks since prior radioimmunoconjugates or toxin immunoconjugates (e.g., iodine I 131 tositumomab [Bexxar] or ibritumomab tiuxetan [Zevalin]) More than 2 weeks since prior investigational agent No prior bortezomib No concurrent systemic corticosteroid at greater than the equivalent dose of 20 mg/day of prednisone, unless for treatment of allergic reactions to CT scan dye No concurrent major surgery No other immunosuppressive agents, unless for treatment of allergic reactions to CT scan dye No other concurrent antilymphoma agents No other concurrent investigational agent Concurrent participation in another nontreatment study allowed if it does not interfere with participation in this study
Sites / Locations
- University of Virginia Cancer Center at UV Health System