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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
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.
Details
| Lead sponsor | Children's Oncology Group |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 28 |
| Start date | 2001-10 |
| Completion | 2005-09 |
Conditions
- Melanoma (Skin)
- Neuroblastoma
- Sarcoma
- Unspecified Childhood Solid Tumor, Protocol Specific
Interventions
- hu14.18-IL2 fusion protein
Primary outcomes
- Determine the MTD and pharmacokinetics of hu14.18-IL2 fusion protein
Determine the MTD of hu14.18-IL2 fusion protein and determine the pharmacokinetics of the fusion protein when given as I.V. injections
Countries
United States, Australia, Canada