Clinical trial NCT00217503 (phase 2, status: completed)
Conditions: lymphoma
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: bortezomib, cyclophosphamide, doxorubicin hydrochloride, etoposide, ganciclovir, valganciclovir, zidovudine
SMILES: ClCCN(CCCl)P1(=O)NCCCO1, ClCCN(CCCl)P1(=O)NCCCO1, COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O, OCCOCCN1CCN(CC1)C(C1=CC=CC=C1)C1=CC=C(Cl)C=C1, NC1=NC2=C(N=CN2COC(CO)CO)C(=O)N1, CC(C)[C@H](N)C(=O)OCC(CO)OCN1C=NC2=C1NC(N)=NC2=O, CC1=CN([C@H]2C[C@H](N=[N+]=[N-])[C@@H](CO)O2)C(=O)NC1=O
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed primary effusion lymphoma (PEL) involving a body cavity

               -  Kaposi's sarcoma associated-herpesvirus

               -  Any anatomic site or distribution of involvement allowed

               -  HIV infection allowed

          -  Previously treated or untreated disease

          -  No mass lesions in the brain (for patients receiving bevacizumab during study
             treatment)

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  ECOG 0-3* NOTE: *ECOG 4 allowed if due to a mechanical effect of the PEL that can be
             corrected by effusion drainage resulting in improved performance status to ECOG 3 or
             better

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Absolute neutrophil count > 1,000/mm^3

          -  Platelet count > 75,000/mm^3

          -  No active bleeding or coagulopathy (for patients receiving bevacizumab during study
             treatment)

        Hepatic

          -  AST and ALT < 3 times upper limit of normal (ULN) (6 times ULN if due to
             hyperalimentation)

          -  Bilirubin < 2.0 mg/dL OR

          -  Total bilirubin ≤ 4.5 mg/dL AND direct bilirubin < 0.4 mg/dL (for patients with
             Gilbert's syndrome or receiving protease-inhibitor therapy)

        Renal

          -  Creatinine ≤ 1.5 mg/dL OR

          -  Creatinine clearance > 50 mL/min

        Cardiovascular

          -  Patients receiving bevacizumab during study treatment must meet the following
             criteria:

               -  No deep venous or arterial thrombosis within the past 6 months

               -  No uncontrolled hypertension (i.e., systolic blood pressure [BP] > 160 mm Hg or
                  diastolic BP > 95 mm Hg)

               -  No unstable angina

               -  No New York Heart Association class II-IV congestive heart failure

               -  No cardiac arrhythmia requiring medication

               -  No clinically significant peripheral artery disease

               -  No peripheral vascular disease ≥ grade 2

               -  No prior myocardial infarction

               -  No transient ischemic attack or cerebral vascular accident within the past 6
                  months

               -  No other clinically significant cardiovascular disease

        Neurologic

          -  Patients receiving bevacizumab during study treatment must meet the following
             criteria:

               -  No uncontrolled seizure disorder

               -  No CNS bleeding within the past 6 months

               -  No other substantial CNS disease

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No other malignancy requiring treatment that would preclude study treatment,
             including, but not limited to, any of the following:

               -  Life-threatening Kaposi's sarcoma

               -  Non-resectable lung cancer

               -  Acute leukemia

          -  No grade IV organ dysfunction unrelated to PEL

          -  No infection requiring chronic systemic therapy that would preclude study treatment
             (except HIV, hepatitis B, or hepatitis C), including, but not limited to, any of the
             following:

               -  Invasive aspergillosis

               -  End-organ cytomegalovirus (CMV)

                    -  CMV retinitis (e.g., ocular implants not requiring systemic therapy) allowed
                       if controlled with local therapy

          -  No other condition or circumstance that would preclude study participation

          -  No gastrointestinal bleeding within the past 6 months (for patients receiving
             bevacizumab during study treatment)

          -  No pathological condition that would confer a high risk for bleeding (for patients
             receiving bevacizumab during study treatment)

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No live virus vaccines (e.g., vaccinia or rotavirus) or bacterial vaccines during and
             for 3 months after completion of study treatment

        Chemotherapy

          -  No prior cumulative anthracycline dose > 450 mg/m^2 (unless cardiac ejection fraction
             normal)

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  Not specified

        Surgery

          -  Not specified

        Other

          -  No concurrent chronic daily aspirin ≥ 325 mg/day or nonsteroidal medication that
             interferes with platelet function (for patients receiving bevacizumab during study
             treatment)

          -  No concurrent therapeutic anticoagulation (INR > 1.5) unless patient is on full-dose
             warfarin (for patients receiving bevacizumab during study treatment)

               -  Full-dose anticoagulants allowed provided both of the following criteria are met:

                    -  INR normal

                    -  On a stable dose of warfarin or low-molecular weight heparin