drugset / Trial / NCT02605421
Myeloablative Consolidation Therapy and Tandem Autologous Stem Cell Rescue in Patients With High-Risk Neuroblastoma
NaSingle-groupOpen-labelTreatment
Summary
This is a phase II single center study to administer two courses of myeloablative consolidation chemotherapy each followed by an autologous peripheral blood stem cell (PBSC) rescue in patients with high-risk neuroblastoma who have completed induction chemotherapy (independent of this study). Ideally, patients should begin consolidation chemotherapy no later than 8 weeks after the start of Induction Cycle #5; however it is strongly recommended to begin consolidation within 4-6 weeks after the start of Induction Cycle #5.
Timeline
- Start
- 2016-06
- Primary completion
- 2026-10-01
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | — | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Subject | Etoposide | Small molecule | — | Intravenous |
| Subject | Melphalan | Small molecule | — | Intravenous |
| Subject | Thiotepa | Other / unclassified | — | Intravenous |
| Background | Granulocyte colony-stimulating factor | Protein / enzyme biologic | 5 ug/kg | Subcutaneous |