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Multicenter Observer-Blind Randomized Phase II Parallel Study Comparing Three Doses of Subcutaneous Interleukin 2 After Megatherapy and Peripheral Stem Cell Reinfusion in Stage 4 Neuroblastoma in Patients Over 1 Year of Age (NCT00003743)

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill neuroblastoma cells. PURPOSE: Phase II trial to study the effectiveness of interleukin-2 in treating children with stage IV neuroblastoma who have received induction therapy and peripheral stem cell transplantation.
  • Biological: aldesleukin
    Ages eligible for Study
    1 Years to 21 Years
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    OBJECTIVES: I. Determine the maximum dose that can be administered in an ambulatory setting among three dose regimens in children with stage IV neuroblastoma. II. Determine the highest tolerated level if a sustained increase in NK-cell number is observed. III. Determine the type, duration, and reversibility of side effects at the three dose levels. IV. Confirm the chosen dose level.

    OUTLINE: This is a randomized, parallel, open label, multicenter study. Part I: Patients receive one of three doses of interleukin-2 (IL-2) subcutaneously beginning 20 to 40 days following autologous stem cell reinfusion. IL-2 is administered for 5 consecutive days every 14 days for up to 3 months, for a total of 6 courses. Cohorts of 5 patients are entered at each dose level of IL-2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 3 or more patients experience dose limiting toxicity. Part II: Additional patients receive IL-2 at the dose level below the MTD. These patients are stratified according to prior therapy (melphalan plus megatherapy vs total body irradiation or meta-iodobenzylguanidine scan plus melphalan vs busulfan containing regimens). Patients are followed at 1 week.

    PROJECTED ACCRUAL: Approximately 25 patients will be accrued for this study.

    1 locations

    Austria (1)
    • St. Anna Children's Hospital
      Not specified
      Vienna, Austria, A-1090
    Status:
    unknown
    Type:
    Interventional
    Phase:
    Start:
    28 February, 1997
    Updated:
    15 September, 2013
    Participants:
    25
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