NCT00003750

Biological Therapy in Treating Children With Refractory or Recurrent Neuroblastoma or Other Tumors

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Melanoma (Skin)
• Neuroblastoma
• Sarcoma
• Unspecified Childhood Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
BIOLOGICAL	hu14.18-IL2 fusion protein

Timeline

• Start date: 2001-10-01
• Primary completion: 2005-01-01
• Completion: 2005-09-01
• First posted: 2003-01-27
• Last updated: 2014-08-08

Locations

59 sites across 3 countries: United States, Australia, Canada