Lymphoma Clinical Trial
Official title:
A Phase II Trial of Doxil, Rituximab, Cyclophosphamide, Vincristine, and Prednisone (DR-COP) in Patients With Newly Diagnosed AIDS-Associated B-Cell Non-Hodgkin's Lymphoma
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.
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.
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