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Randomized Trial of CHOP Chemotherapy With or Without Rituximab (Chimeric Anti-CD20 Antibody) for HIV-Associated Non-Hodgkin's Lymphoma (NCT00003595)

Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without monoclonal antibody therapy in treating patients who have previously untreated HIV-associated non-Hodgkin's lymphoma. Drugs used in chemotherapy use 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. It is not yet known whether combination chemotherapy plus monoclonal antibody therapy is more effective than combination chemotherapy alone in treating HIV-associated non-Hodgkin's lymphoma.
  • Biological: filgrastim
    • Biological: rituximab
      • Drug: CHOP regimen
        • Drug: cyclophosphamide
          • Drug: doxorubicin hydrochloride
            • Drug: prednisone
              • Drug: vincristine sulfate
                Ages eligible for Study
                18 Years and older
                Genders eligible for Study
                All
                Accepts Healthy Volunteers
                No
                OBJECTIVES:

                I. Compare the efficacy of CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) with or without rituximab in patients with previously untreated HIV-associated non-Hodgkin's lymphoma.

                II. Determine the efficacy of rituximab as maintenance therapy following remission induction with CHOP in these patients.

                III. Determine the effect of rituximab on the immune system and HIV viral load in these patients.

                IV. Determine the relationship between EBV load and the presence of EBV in lymphoma tumor cells of these patients.

                V. Compare the effect of CHOP with or without rituximab on EBV load in these patients.

                OUTLINE: This is a randomized, multicenter study.

                Patients are stratified by extent of disease (stage I/II vs III/IV). Patients are randomized to 1 of 2 treatment arms:

                Arm I: Patients receive cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 3 and oral prednisone on days 3-7. Patients receive rituximab on day 1. Treatment repeats every 3 weeks for a minimum of 4 courses or 2 courses beyond complete response in the absence of disease progression or unacceptable toxicity. Patients with stage I, stage IE (including bulky), or nonbulky stage II or IIE disease receive 3 courses of chemotherapy with rituximab followed by radiotherapy beginning 3 weeks after completion of the third course. Patients who achieve partial response for a minimum of 28 days or complete response receive maintenance rituximab IV beginning on day 28 of the final course of chemotherapy. Maintenance rituximab treatment repeats every 4 weeks for 3 courses.

                Arm II: Patients receive cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1 and oral prednisone on days 1-5. Treatment repeats every 3 weeks for a minimum of 4 courses or 2 courses beyond complete response. Patients with stage I, stage IE (including bulky), or nonbulky stage II or IIE disease receive 3 courses of chemotherapy. Patients receive radiotherapy beginning 3 weeks after completion of the third course of chemotherapy.

                Both arms: Patients receive filgrastim (G-CSF) subcutaneously beginning on day 4 and continuing through day 13 of each chemotherapy course or until blood counts recover.

                Patients are followed every 4 weeks for 1 year and then every 2 months until death.

                13 locations

                United States (13)
                • USC/Norris Comprehensive Cancer Center and Hospital
                  Los Angeles, California, United States, 90033-0804
                • Jonsson Comprehensive Cancer Center, UCLA
                  Los Angeles, California, United States, 90095-1781
                • San Francisco General Hospital Medical Center
                  San Francisco, California, United States, 94110
                • Sylvester Cancer Center, University of Miami
                  Miami, Florida, United States, 33136
                • Robert H. Lurie Comprehensive Cancer Center, Northwestern University
                  Chicago, Illinois, United States, 60611-3013
                • Massachusetts General Hospital
                  Boston, Massachusetts, United States, 02114-2617
                • University Hospital/New Jersey Cancer Center
                  Newark, New Jersey, United States, 07103
                • NYU School of Medicine's Kaplan Comprehensive Cancer Center
                  New York, New York, United States, 10016
                • Memorial Sloan-Kettering Cancer Center
                  New York, New York, United States, 10021
                • Mount Sinai School of Medicine
                  New York, New York, United States, 10029
                • Herbert Irving Comprehensive Cancer Center
                  New York, New York, United States, 10032
                • Ireland Cancer Center
                  Cleveland, Ohio, United States, 44106-5065
                • Arthur G. James Cancer Hospital - Ohio State University
                  Columbus, Ohio, United States, 43210-1240
                Status:
                completed
                Type:
                Interventional
                Phase:
                Start:
                31 December, 1998
                Updated:
                06 February, 2013
                Participants:
                120
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