Combination Chemotherapy and Rituximab in Treating Patients With HIV-Associated Stage I, Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma
Condition: AIDS-related Diffuse Large Cell Lymphoma; AIDS-related Immunoblastic Large Cell Lymphoma; AIDS-related Peripheral/Systemic Lymphoma; AIDS-related Small Noncleaved Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Large-Cell, Immunoblastic; Plasmablastic Lymphoma
Intervention: rituximab; etoposide; doxorubicin hydrochloride; vincristine sulfate; prednisone; cyclophosphamide; laboratory biomarker analysis
Intervention description: Given IV; Given IV; Given IV; Given IV; Given orally; Given IV; Correlative studies
Intervention MeSH terms: Prednisone; Cyclophosphamide; Rituximab; Doxorubicin; Liposomal doxorubicin; Etoposide; Vincristine; Etoposide phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 106.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase II trial is studying how well giving combination chemotherapy together
      with rituximab works in treating patients with HIV-associated stage I, stage II, stage III,
      or stage IV non-Hodgkin's lymphoma. Drugs used in chemotherapy work in different ways to stop
      cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as
      rituximab can locate cancer cells and either kill them or deliver cancer-killing substances
      to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy
      may kill more cancer cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previously untreated histologically or cytologically documented B-cell non-Hodgkin's
             lymphoma; the following histologies are eligible: diffuse large B-cell lymphoma,
             high-grade large cell immunoblastic lymphoma, anaplastic large cell lymphoma,
             Burkitt's lymphoma, high-grade B-cell lymphoma, Burkitt-like (small non-cleaved
             lymphoma)

          -  Tumors must be CD20 positive

          -  Documented HIV infection: documentation may be serologic (ELISA, western blot),
             culture, or quantitative PCR or bDNA assays

          -  Evaluable or measurable disease

          -  Stage I and IE or Stage II-IV disease patients

          -  ANC >= 1000 cells/mm^3

          -  Platelet count >= 75,000/mm^3 unless cytopenias are secondary to lymphoma

          -  All patients must be off colony stimulating factor therapy at least 24 hours prior to
             chemotherapy

          -  Transaminase =< 5 times the upper limit of normal unless secondary to hepatic
             infiltration with lymphoma or isolated hyperbilirubinemia associated with the use of
             indinavir or other antiretrovirals

          -  Total Bilirubin < 2.0 unless secondary to hepatic infiltration with lymphoma or
             isolated hyperbilirubinemia associated with the use of indinavir or other
             antiretrovirals; for bilirubin > 3.0 due to hepatic involvement the initial dose of
             doxorubicin will be decreased by 50% and the initial dose of vincristine will be
             omitted

          -  Creatinine < 2.0 unless due to lymphoma

          -  KPS >= 50 (ECOG PS 0, 1, or 2)

          -  Able to give consent

          -  Female patients must have a negative pregnancy test within 72 hours of entering into
             the study; males and females must agree to use adequate birth control if conception is
             possible during the study; women must avoid pregnancy and men avoid fathering children
             while in the study

          -  Patients already receiving erythropoeitin or G-CSF are eligible

          -  Patients must have a left ventricular ejection fraction that is at or above the lower
             institutional limits of normal, as assessed by nuclear scan or echocardiogram obtained
             within 12 weeks of registration

          -  Lymphomatous meningitis (patients with a positive CSF cytology are eligible)

        Exclusion Criteria:

          -  Previous chemotherapy or radiotherapy for this lymphoma

          -  Primary Central Nervous System Lymphoma (parenchymal brain or spinal cord tumor)

          -  Acute active HIV-associated opportunistic infection requiring antibiotic treatment;
             patients with mycobacterium avium are not excluded; chronic therapy with potentially
             myelosuppressive agents is allowed provided that entry hematologic criteria are met

          -  Concurrent malignancy (excluding in situ cervical cancer, or non-metastatic
             non-melanomatous skin cancer, or Kaposi's sarcoma not requiring systemic chemotherapy)

          -  Previous therapy with rituximab within 12 months; patients treated with rituximab more
             than 12 months earlier are eligible only if it was given for indications other than
             the treatment of intermediate- or high-grade lymphoma (eg, low-grade lymphoma or ITP)