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A Randomized Pre-Phase II Trial of Interleukin-2, Interleukin-12, or No Additional Therapy Following Response to Ifosfamide/Etoposide Chemotherapy for Refractory HIV-Associated Non-Hodgkin's Lymphoma (NCT00003575)

Phase II trial to compare the effectiveness of interleukin-12 following chemotherapy in treating patients who have refractory HIV-associated non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person' white blood cells to kill cancer cells.
  • Biological: filgrastim
    • Biological: recombinant interleukin-12
      • Drug: etoposide
        • Drug: ifosfamide
          Ages eligible for Study
          18 Years to 70 Years
          Genders eligible for Study
          Accepts Healthy Volunteers

          I. Determine the efficacy of interleukin-12 (IL-12) by evaluating its effect on remission duration after response to second line chemotherapy with ifosfamide and etoposide in patients with HIV-associated non-Hodgkin's lymphoma.

          II. Determine the safety of IL-12 when administered as maintenance therapy in these patients.

          III. Evaluate overall survival of this patient population. IV. Evaluate serum and tissue cytokine levels in these patients. V. Evaluate the effect of IL-12 on HIV viral load and on functional T-cell assays in these patients.

          VI. Evaluate the effect of IL-12 on Epstein-Barr Virus (EBV) viral load in these patients.

          OUTLINE: This is an open label study.

          All patients receive ifosfamide IV by continuous infusion for 2 days, etoposide IV over 2 hours daily on days 1 and 2, and filgrastim (G-CSF) subcutaneously (SC) daily on days 4-13. Courses are repeated every 21 days. Patients who have complete or partial remission after a minimum of 4 courses of chemotherapy receive maintenance therapy consisting of interleukin-12 SC twice weekly beginning on day 28 of the final chemotherapy course and continuing for 6 months or until disease progression. All patients also receive combination antiretroviral therapy during study.

          Patients are followed every month for one year, then every 2 months thereafter.

          10 locations

          United States (10)
          • USC/Norris Comprehensive Cancer Center
            Not specified
            Los Angeles, California, United States, 90033-0800
          • San Francisco General Hospital Medical Center
            Not specified
            San Francisco, California, United States, 94110
          • Sylvester Cancer Center, University of Miami
            Not specified
            Miami, Florida, United States, 33136
          • Robert H. Lurie Comprehensive Cancer Center, Northwestern University
            Not specified
            Chicago, Illinois, United States, 60611
          • Massachusetts General Hospital
            Not specified
            Boston, Massachusetts, United States, 02114-2617
          • University Hospital/New Jersey Cancer Center
            Not specified
            Newark, New Jersey, United States, 07103
          • NYU School of Medicine's Kaplan Comprehensive Cancer Center
            Not specified
            New York, New York, United States, 10016
          • Memorial Sloan-Kettering Cancer Center
            Not specified
            New York, New York, United States, 10021
          • Mount Sinai School of Medicine
            Not specified
            New York, New York, United States, 10029
          • Arthur G. James Cancer Hospital - Ohio State University
            Not specified
            Columbus, Ohio, United States, 43210
          31 December, 1998
          06 February, 2013
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