EPOCH and Rituximab to Treat Non-Hodgkin's Lymphoma in Patients With HIV Infection
Lymphoma, AIDS-related, Lymphoma, Large B-Cell, Diffuse
About this trial
This is an interventional treatment trial for Lymphoma, AIDS-related focused on measuring AIDS, Malignancy, Antiretroviral, Chemotherapy, Monoclonal
Eligibility Criteria
INCLUSION CRITERIA: Aggressive B-lymphocyte antigen CD20 (CD20) positive Diffuse Large B-cell lymphoma confirmed by Laboratory of Pathology, National Cancer Institute (NCI). Note: Participants with aggressive B-cell lymphoma of the plasmablastic lymphoma sub-type who do not have surface CD20 expression, are also eligible. Human immunodeficiency virus (HIV) + serology. All stages (I-IV) of disease. Eastern Cooperative Oncology Group (ECOG) Performance status 0-4 Non-Hodgkin's Lymphoma (NHL) previously untreated with cytotoxic chemotherapy; however, participants may be entered if they have had prior cyclophosphamide for an urgent problem at diagnosis (e.g., epidural cord compression, superior vena cava syndrome) and/or a single dose of intrathecal methotrexate (MTX) at the time of the pre-treatment diagnostic lumbar puncture Age greater than or equal to 18 years Laboratory tests (unless impairment due to respective organ involvement by tumor): Creatinine less than or equal to 1.5 mg/dl or creatinine clearance greater than or equal to 50 ml/min Bilirubin less than 2.0 mg/dl, or total bilirubin less than or equal to 4.5 mg/dl with direct fraction less than or equal to 0.3 mg/dl in participants for whom these abnormalities are felt to be due to protease inhibitor therapy Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 3x upper limit of normal (ULN) (AST and ALT less than or equal to 6x ULN for participants on hyperalimentation for whom these abnormalities are felt to be due to the hyperalimentation) Absolute neutrophil count (ANC) greater than or equal to 1000/mm(3) Platelet greater than or equal to 75,000/mm(3) (unless impairment due to Immune thrombocytopenic purpura (ITP) Ability of participant to provide informed consent. EXCLUSION CRITERIA: Previous rituximab Pregnancy or nursing. - Doxorubicin, etoposide, vincristine and cyclophosphamide are teratogenic and may be excreted in milk. Current clinical heart failure or symptomatic ischemic heart disease. Serious underlying medical condition or infection other than HIV that would contraindicate subcutaneous (SC)-rituximab, etoposide phosphate, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride (hydroxydaunorubicin (EPOCH-R). Examples include, but are not limited to: Severe Acquired immunodeficiency syndrome (AIDS)-related wasting Sever intractable diarrhea Active inadequately treated opportunistic infection of the central nervous system (CNS) Primary CNS lymphoma Primary CNS lymphoma
Sites / Locations
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Arms of the Study
Arm 1
Experimental
Arm 1-Combination Chemo and Biological Therapy
Combination chemo and biological therapy