Sarcoma Clinical Trial
Official title:
A Phase I/IB Intergroup Trial of the HU14.18-IL2 Fusion Protein in Children With Refractory Neuroblastoma and Other GD2 Positive Tumors
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.
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.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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