drugset / Trial / NCT06438614
A Study Of Naxitamab , Granulocyte Macrophage Colony Stimulating Factor For Patients With Relapsed /Refractory , Soft Tissue or Anti GD2 Immunotherapy Refractory Neuroblastoma
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate safety and efficacy of naxitamab, granulocyte macrophage Colony Stimulating Factor (GM CSF) and Isofosfamide/Carboplatin/Etoposide (NICE) for Patients With Relapsed /Refractory, soft tissue or anti GD2 immunotherapy refractory Neuroblastoma
Timeline
- Start
- 2020-08-20
- Primary completion
- 2023-07-20
- Completion
- 2023-10-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | 400 mg/m2 | Intravenous |
| Subject | Etoposide | Small molecule | 100 mg/m2 | Intravenous |
| Subject | Ifosfamide | Small molecule | 1.5 g | Intravenous |
| Subject | Irinotecan | Small molecule | 50 mg/m2 | Intravenous |
| Subject | Naxitamab | Monoclonal antibody | 2.25 mg/kg | Intravenous |
| Subject | Temozolomide | Small molecule | 150 mg/m2 | Oral |
| Subject | sargramostim | Protein / enzyme biologic | 250 ug/m2 | Subcutaneous |