drugset / Trial / NCT00644696
Study of Irinotecan and Bortezomib in Children With Recurrent/Refractory Neuroblastoma
Phase 1
Completed
18 enrolled
University of Michigan Rogel Cancer Center
Millennium Pharmaceuticals, Inc. · collab
NaSingle-groupOpen-labelTreatment
Summary
This Phase One pediatric trial seeks to take advantage of the susceptibility of neuroblastoma to proteasome inhibitors, proven in vitro, along with the proven in vitro synergy of bortezomib with irinotecan and the successful Phase One pediatric trials of bortezomib to create a treatment using these two drugs in combination to treat refractory/recurrent neuroblastoma in children and young adults 25 and under.
Timeline
- Start
- 2008-04
- Primary completion
- 2012-07
- Completion
- 2012-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bortezomib | Small molecule | 1.2 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 30 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 35 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 40 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 45 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 50 mg/m2 | Intravenous |