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
- 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
- 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.
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete Response Rate (Complete Response and Complete Response Unconfirmed) Defined as Disappearance of All Evidence of Disease Based on Radiographic Findings on CT or MRI .
After cycles 2, 4, 6, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation
Alexandra M. Levine, MD
Beckman Research Institute
United States: Institutional Review Board
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|
|Virginia Mason Medical Center||Seattle, Washington 98111|
|USC/Norris Comprehensive Cancer Center and Hospital||Los Angeles, California 90033-0804|
|Rebecca and John Moores UCSD Cancer Center||La Jolla, California 92093-0658|
|Ochsner Cancer Institute at Ochsner Clinic Foundation||New Orleans, Louisiana 70121|
|Albert Einstein Cancer Center at Albert Einstein College of Medicine||Bronx, New York 10461|
|Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis||St. Louis, Missouri 63110|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University||Chicago, Illinois 60611|
|Joan Karnell Cancer Center at Pennsylvania Hospital||Philadelphia, Pennsylvania 19107|
|University of Miami Sylvester Comprehensive Cancer Center - Miami||Miami, Florida 33136|
|UCLA Clinical AIDS Research and Education (CARE) Center||Los Angeles, California 90024|
|Boston University Cancer Research Center||Boston, Massachusetts 02118|