Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed AIDS-Related B-Cell Non-Hodgkin's Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer
      cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,
      such as rituximab, can block cancer growth in different ways. Some find cancer cells and help
      kill them or carry cancer-killing substances to them. Others interfere with the ability of
      cancer cells to grow and spread. Giving combination chemotherapy together with rituximab may
      kill more cancer cells.

      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together
      with rituximab works in treating patients with newly diagnosed AIDS-related B-cell
      non-Hodgkin's lymphoma.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the complete response rate (complete response and complete response
           unconfirmed) in patients with newly diagnosed, AIDS-related B-cell non-Hodgkin's
           lymphoma treated with doxorubicin hydrochloride liposome, rituximab, cyclophosphamide,
           vincristine, and prednisone (DR-COP).

        -  Determine the duration of response (relapse-free survival) in patients treated with this
           regimen.

        -  Determine the median survival time of patients treated with this regimen.

        -  Determine rate of bacterial, fungal, and opportunistic infections in patients treated
           with this regimen.

      Secondary

        -  Determine, preliminarily, the relationship between MDR-1 expression in tumor tissue and
           response to therapy in patients treated with this regimen.

        -  Determine, preliminarily, any relationship between response and survival and BCL-2
           expression in tumor tissue in patients treated with this regimen.

        -  Determine any relationship between development of bacterial, fungal, and/or
           opportunistic infections and baseline CD4 lymphocyte count, HIV-1 RNA level, and
           quantitative immunoglobulin levels, or changes in quantitative immunoglobulin levels
           over time in patients treated with this regimen.

        -  Compare the results of positron emission tomography (PET) scanning with traditional CT
           scans in predicting response to therapy in these patients.

        -  Examine the relationship between chemotherapeutic drug levels and receipt of specific
           antiretroviral and/or anti-infective medications in these patients.

        -  Examine the mortality and the causes of death in patients treated with this regimen.

        -  Determine event-free survival at 1 year.

      OUTLINE: This is a nonrandomized, multicenter study.

      Patients receive doxorubicin hydrochloride liposome IV over 90 minutes, rituximab IV over 5-7
      hours, cyclophosphamide IV over 1 hour, and vincristine IV over 1-2 minutes on day 1 and oral
      prednisone on days 1-5. Patients also receive filgrastim (G-CSF), sargramostim (GM-CSF), or
      pegfilgrastim beginning on day 3 and continuing until blood counts recover. Treatment repeats
      every 21-28 days for up to 8 courses in the absence of disease progression or unacceptable
      toxicity.

      Patients undergo laboratory/biomarker studies at baseline and after every 2 courses of
      chemotherapy. Tissue is examined by immunohistochemistry for BCL-2, Ki67, and MDR-1, along
      with other markers.

      After completion of study treatment, patients are followed periodically for 3 years.

      PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.
    

Intervention name(s): filgrastim; pegfilgrastim; rituximab; sargramostim; cyclophosphamide; pegylated liposomal doxorubicin hydrochloride; prednisone; vincristine sulfate; immunohistochemistry staining method; laboratory biomarker analysis
Intervention type(s): Biological; Biological; Biological; Biological; Drug; Drug; Drug; Drug; Other; Other
Intervention description(s): Supportive therapy: GF therapy with G-CSF, GM-CSF, or pegfilgrastim will be used in all patients, beginning on Day 3 of each cycle, until post nadir of blood counts from each chemotherapy cycle.; GF therapy with G-CSF, GM-CSF, or pegfilgrastim will be used in all patients, beginning on Day 3 of each cycle, until post nadir of blood counts from each chemotherapy cycle.; 375 mg/m2 IV Day 1 of each cycle; GF therapy with G-CSF, GM-CSF, or pegfilgrastim will be used in all patients, beginning on Day 3 of each cycle, until post nadir of blood counts from each chemotherapy cycle.; 750 mg/m2 IV Day 1 of each cycle; 40 mg/m2 IV Day 1 of each cycle; 100 mg PO Days 1-5 of each cycle; 1.4 mg/m2 IV Day 1 (2.0 mg maximum) of each cycle; tissue specimen collected at baseline; tissue specimen collected at baseline
Intervention MeSH terms: Prednisone; Cyclophosphamide; Rituximab; Doxorubicin; Liposomal doxorubicin; Vincristine; Sargramostim
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: contiguous stage II grade 3 follicular lymphoma; noncontiguous stage II grade 3 follicular lymphoma; stage I grade 3 follicular lymphoma; stage III grade 3 follicular lymphoma; stage IV grade 3 follicular lymphoma; AIDS-related diffuse large cell lymphoma; contiguous stage II adult diffuse large cell lymphoma; noncontiguous stage II adult diffuse large cell lymphoma; stage I adult diffuse large cell lymphoma; stage III adult diffuse large cell lymphoma; stage IV adult diffuse large cell lymphoma; AIDS-related immunoblastic large cell lymphoma; contiguous stage II adult immunoblastic large cell lymphoma; noncontiguous stage II adult immunoblastic large cell lymphoma; stage I adult immunoblastic large cell lymphoma; stage III adult immunoblastic large cell lymphoma; stage IV adult immunoblastic large cell lymphoma; AIDS-related peripheral/systemic lymphoma