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A Phase I/IB Intergroup Trial of the HU14.18-IL2 Fusion Protein in Children With Refractory Neuroblastoma and Other GD2 Positive Tumors (NCT00003750)

National Cancer Institute (NCI)
RATIONALE: Biological therapies such as hu14.18-interleukin-2 fusion protein use different ways to stimulate the immune system and stop cancer cells from growing. PURPOSE: Phase I trial to study the effectiveness of hu14.18-interleukin-2 fusion protein in treating children who have refractory or recurrent neuroblastoma or other tumors.
  • Biological: hu14.18-IL2 fusion protein
    Ages eligible for Study
    up to 21 Years
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    OBJECTIVES:

    - Determine the maximum tolerated dose of hu14.18-interleukin-2 fusion protein in children with refractory or recurrent neuroblastoma or other GD2-positive tumors.

    - Determine the toxicity and pharmacokinetics of the fusion protein in these patients.

    - Determine the effect of the fusion protein on systemic immune modulation in these patients.

    - Quantitate the antifusion protein antibodies in patients treated with fusion protein.

    - Evaluate antitumor responses resulting from this fusion protein regimen in these patients.

    OUTLINE: This is a dose-escalation study.

    Patients receive hu14.18-interleukin-2 (hu14.18-IL2) fusion protein IV over 4 hours once daily on days 1-3. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

    Cohorts of 3-6 patients receive escalating doses of hu14.18-IL2 fusion protein until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

    Patients are followed every 2 months for 1 year, every 6 months for 3 years, and then annually for 5 years.

    PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study within 1 year.

    59 locations

    Status:
    completed
    Type:
    Interventional
    Phase:
    Start:
    30 September, 2001
    Updated:
    05 August, 2014
    Participants:
    28
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