drugset / Trial / NCT04947501
A Study of N9 Chemotherapy in Children With Neuroblastoma
NaSingle-groupOpen-labelTreatment
Summary
The purpose of the study is to find out whether N9 is a safe and effective treatment for children with neuroblastoma. N9 includes 3 different combinations of chemotherapy drugs that are given at different times - Cyclophosphamide, topotecan, and vincristine (CTV), Ifosfamide, carboplatin, and etoposide (ICE), Cyclophosphamide, doxorubicin, and vincristine (CDV).
Timeline
- Start
- 2021-06-22
- Primary completion
- 2026-06-22
- Completion
- 2026-06-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | 13.3 mg/kg | Intravenous |
| Subject | Carboplatin | Small molecule | 400 mg/m2 | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | 70 mg/kg | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | 2100 mg/m2 | Intravenous |
| Subject | Doxorubicin | Other / unclassified | 25 mg/m2 | Intravenous |
| Subject | Etoposide | Small molecule | 3.3 mg/kg | Intravenous |
| Subject | Etoposide | Small molecule | 100 mg/m2 | Intravenous |
| Subject | Ifosfamide | Small molecule | 50 mg/kg | Intravenous |
| Subject | Ifosfamide | Small molecule | 1500 mg/m2 | Intravenous |
| Subject | Topotecan | Small molecule | 2 mg/m2 | Intravenous |
| Subject | Vincristine | Small molecule | 0.022 mg/kg | Intravenous |
| Subject | Vincristine | Small molecule | 0.067 mg/kg | Intravenous |
| Subject | Vincristine | Small molecule | 0.67 mg/m2 | Intravenous |
| Subject | Vincristine | Small molecule | 2 mg/m2 | Intravenous |
| Background | 2-MERCAPTOETHANESULFONIC ACID | Small molecule | 70 mg/kg | Intravenous |
| Background | 2-MERCAPTOETHANESULFONIC ACID | Small molecule | 1500 mg/m2 | Intravenous |
| Background | 2-MERCAPTOETHANESULFONIC ACID | Small molecule | 2100 mg/m2 | Intravenous |