drugset / Trial / NCT01592045
ch14.18 Pharmacokinetic Study in High-risk Neuroblastoma
RandomizedCrossoverOpen-labelTreatment
Summary
The purpose of this study is to compare the pharmacokinetics (blood levels) and safety of chimeric (ch) 14.18 manufactured by two independent drug makers (United Therapeutics \[UTC\] or the National Cancer Institute \[NCI\]).
Timeline
- Start
- 2012-08
- Primary completion
- 2014-06
- Completion
- 2014-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dinutuximab | Monoclonal antibody | 17.5 mg/m2 | Intravenous |
| Subject | Dinutuximab | Monoclonal antibody | 25 mg/m2 | Intravenous |
| Background | Isotretinoin | Other / unclassified | 2.67 mg/kg | Oral |
| Background | Isotretinoin | Other / unclassified | 80 mg/m2 | Oral |
| Background | aldesleukin | Protein / enzyme biologic | 3 unknown | Intravenous |
| Background | aldesleukin | Protein / enzyme biologic | 4.5 unknown | Intravenous |
| Background | sargramostim | Protein / enzyme biologic | 250 ug/m2 | Subcutaneous |