A Phase I/II Trial of VELCADE & Gemcitabine for Patients With Relapsed or Refractory Aggressive B- and T-cell Non-Hodgkin's Lymphoma
Lymphoma
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent grade 3 follicular lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, recurrent mycosis fungoides/Sezary syndrome
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of B- or T-cell non-Hodgkin's lymphoma (NHL) Intermediate histology B-cell NHL, including any of the following: Diffuse large B-cell lymphoma Transformed large cell lymphoma Any T-cell NHL histology Cutaneous T-cell lymphoma (CTCL) or mycosis fungoides (MF) allowed Relapsed or refractory disease, defined as disease progressed after prior complete remission (CR), partial remission (PR), or stable disease (SD) to last therapy OR failure to achieve CR, PR, or SD after completion of last therapy Must have received 1-3 prior therapeutic regimens Cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (CHOP) AND cyclophosphamide, vincristine, and prednisone (CVP) OR CHOP with rituximab (CHOP-R) AND CVP with rituximab (CVP-R) is considered 1 regimen Monoclonal antibody (e.g., rituximab) given as maintenance therapy is considered 1 regimen Salvage chemotherapy followed by an autologous stem cell transplant is considered 1 regimen No more than 7 prior therapeutic regimens for patients with CTCL or MF No mantle cell lymphoma PATIENT CHARACTERISTICS: ECOG performance status 0-2 Life expectancy > 3 months Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 At least 50,000/mm^3 if documented bone marrow involvement Hemoglobin ≥ 8.0 g/dL AST and ALT ≤ 3 times upper limit of normal (ULN) Alkaline phosphatase ≤ 3 times ULN Bilirubin ≤ 2 times ULN Creatinine ≤ 2.0 mg/dL No known history of HIV infection No other active infection No uncontrolled hypertension No peripheral neuropathy ≥ grade 2 within the past 2 weeks No myocardial infarction within the past 6 months No New York Heart Association class III or IV heart failure No uncontrolled angina No severe uncontrolled ventricular arrhythmias No acute ischemia or active conduction system abnormalities by ECG No hypersensitivity to bortezomib, boron, or mannitol Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier-method contraception No serious medical or psychiatric illness that would preclude study participation PRIOR CONCURRENT THERAPY: Prior autologous and/or allogeneic stem cell transplantation allowed More than 3 weeks since prior chemotherapy, radiotherapy, or immunotherapy More than 3 weeks since prior systemic biologic anticancer therapy More than 3 weeks since prior systemic corticosteroids (e.g., oral prednisone > 10 mg per day) More than 2 weeks since prior investigational drug No prior bortezomib or gemcitabine hydrochloride No other concurrent systemic cytotoxic chemotherapy or investigational agents
Sites / Locations
- Northwestern University
- Veterans Affairs Medical Center - Lakeside Chicago
- University of Chicago Cancer Research Center
Arms of the Study
Arm 1
Experimental
Gemcitabine 800 mg/m2 + Bortezomib IVP over 3-5 seconds
Gemcitabine dose of 800 mg/m2 over 30 minutes followed by Bortezomib IVP given over 3-5 seconds on day 1 and day 15 of each cycle every 28 days for up to 8 cycles.