Finding studies
Finding studies
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Lead
AIDS Malignancy Consortium
With
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.
Age
18–120
Sex
ALL
Healthy volunteers
Not accepted
