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A Phase II Study of DAB 389 IL-2, an Interleukin-2 Fusion Toxin, for Previously Treated Stage II, III, and IV Follicular Low-Grade Non-Hodgkin's Lymphoma (NCT00003615)

National Cancer Institute (NCI)
RATIONALE: Immunotoxins such as denileukin diftitox can locate cancer cells and kill them without harming normal cells. This may be an effective treatment for non-Hodgkin's lymphoma. PURPOSE: Phase II trial to study the effectiveness of denileukin diftitox in treating patients who have non-Hodgkin's lymphoma that has not responded to previous treatment.
  • Biological: denileukin diftitox
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    OBJECTIVES: I. Determine the objective response rate in patients with previously treated stage I, II, III, or IV low- or intermediate-grade B-cell non-Hodgkin's lymphoma treated with denileukin diftitox. II. Determine the time to progression, duration of remission, and time to treatment failure in patients after treatment with this therapy. III. Determine the toxicity of this therapy in these patients. IV. Correlate the results of the inteleukin-2 receptor assay with treatment outcomes in these patients.

    OUTLINE: Patients are stratified according to interleukin-2 receptor classification (positive vs negative). Patients receive immunotoxin therapy with denileukin diftitox IV over 15-60 minutes on days 1-5. Treatment repeats every 21 days for 2-6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

    PROJECTED ACCRUAL: A total of 33 patients will be accrued for the interleukin-2 (IL-2) receptor-positive stratum and a total of 11-44 patients will be accrued for the IL-2 receptor-negative stratum.

    10 locations

    United States (10)
    • Robert H. Lurie Comprehensive Cancer Center, Northwestern University
      Chicago, Illinois, United States, 60611-3013
    • Beth Israel Deaconess Medical Center
      Boston, Massachusetts, United States, 02215
    • CCOP - Southern Nevada Cancer Research Foundation
      Las Vegas, Nevada, United States, 89106
    • Trinitas Hospital - Jersey Street Campus
      Elizabeth, New Jersey, United States, 07201
    • Hunterdon Regional Cancer Center
      Flemington, New Jersey, United States, 08822
    • Hackensack University Medical Center
      Hackensack, New Jersey, United States, 07601
    • Morristown Memorial Hospital
      Morristown, New Jersey, United States, 07962-1956
    • Riverview Medical Center - Booker Cancer Center
      Red Bank, New Jersey, United States, 07701
    • Overlook Hospital
      Summit, New Jersey, United States, 07902-0220
    • CCOP - Geisinger Clinic and Medical Center
      Danville, Pennsylvania, United States, 17822-2001
    Status:
    completed
    Type:
    Interventional
    Phase:
    Start:
    28 February, 1999
    Updated:
    25 January, 2010
    Participants:
    77
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