drugset / Trial / NCT02169609
Safety Study of Dinutuximab Combined With Immunotherapy to Treat Neuroblastoma
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate safety of the triple COG schema with the monoclonal antibody Dinutuximab + cytokines (GM-CSF and IL2) and isotretinoin (13-cis-retinoic acid, or RA) in patients with high-risk neuroblastoma.
Timeline
- Start
- 2014-11-26
- Primary completion
- 2016-12-26
- Completion
- 2018-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dinutuximab | Monoclonal antibody | 17.5 mg/m2 | Intravenous |
| Subject | Isotretinoin | Other / unclassified | 5.33 mg/kg | Oral |
| Subject | Isotretinoin | Other / unclassified | 160 mg/m2 | Oral |
| Subject | aldesleukin | Protein / enzyme biologic | 3 unknown | Intravenous |
| Subject | sargramostim | Protein / enzyme biologic | 250 ug/m2 | Subcutaneous |