Bortezomib and Antiviral Therapy Followed By Effusion Drainage, Bevacizumab, and Combination Chemotherapy in Treating Patients With Primary Effusion Lymphoma
Lymphoma
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring AIDS-related peripheral/systemic lymphoma
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
Sites / Locations
- Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office