drugset / Trial / NCT02774421
Pilot Study of the Effect of Trastuzumab and GM-CSF on Children With Recurrent Ependymoma
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This study plans to detect the presence of trastuzumab by mass spectroscopy in relapsed posterior fossa ependymoma (PFEPN) tumor specimen pre-treated with a single dose of intrathecal (IT) trastuzumab, as well as to evaluate toxicity of intrathecal trastuzumab in combination with subcutaneous (subQ) Granulocyte-macrophage colony-stimulating factor (GM-CSF) in children with relapsed PFEPN
Timeline
- Start
- 2017-06-12
- Primary completion
- 2025-02-27
- Completion
- 2026-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GM-CSF | Protein / enzyme biologic | 250 ug/m2 | Subcutaneous |
| Subject | Trastuzumab | Monoclonal antibody | — | Intrathecal |