drugset / Trial / NCT06942039
Pilot Study of IT Topotecan and Maintenance Chemotherapy for HR-EBTs in Children < 6 Years, Post Consolidation
NaSingle-groupOpen-labelTreatment
Summary
Pilot study to determine feasibility of adding intrathecal chemotherapy and maintenance therapy after high dose chemotherapy for treatment of newly diagnosed HR-EBTs in patients less than 6 years of age.
Timeline
- Start
- 2025-09-23
- Primary completion
- 2030-12-31
- Completion
- 2032-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | — | Intravenous |
| Subject | Celecoxib | Other / unclassified | — | Oral |
| Subject | Cisplatin | Other / unclassified | — | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Subject | Cytarabine | Small molecule | — | Intrathecal |
| Background | Etoposide | Small molecule | — | Intravenous |
| Subject | Isotretinoin | Other / unclassified | — | Oral |
| Subject | Tamoxifen | Small molecule | — | Oral |
| Subject | Temozolomide | Small molecule | — | Oral |
| Subject | Thiotepa | Other / unclassified | — | Intravenous |
| Subject | Topotecan | Small molecule | — | Intrathecal |
| Subject | Vincristine | Small molecule | — | Intravenous |
| Background | 2-MERCAPTOETHANESULFONIC ACID | Small molecule | — | Intravenous |
| Background | Etoposide | Small molecule | — | — |
| Background | Hydrocortisone | Other / unclassified | — | Intrathecal |
| Background | filgrastim | Protein / enzyme biologic | — | Subcutaneous |