Clinical trial NCT00290706 (phase 1/phase 2, status: terminated)
Conditions: lymphoma
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: bortezomib, gemcitabine hydrochloride
SMILES: ClCCN(CCCl)P1(=O)NCCCO1, NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F
Reason stopped: 
    closed per data monitoring committee due to lack of efficacy
  
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