drugset / Trial / NCT04958486

Combination Intraventricular Chemotherapy Pilot Study: 5-Azacytidine (5-AZA) and Trastuzumab Infusions Into the Fourth Ventricle or Resection Cavity in Children and Adults with Recurrent or Residual Posterior Fossa Ependymoma

NCT04958486

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to establish the safety and tolerability of simultaneous infusions of 5-Azacytidine and trastuzumab into the fourth ventricle of the brain or resection cavity in patients with recurrent posterior fossa ependymoma and to assess the antitumor activity of simultaneous infusions of 5-Azacytidine and trastuzumab into the fourth ventricle of the brain or resection cavity in patients based upon imaging studies and lumbar cerebrospinal fluid (CSF) cytology.

Timeline

Start
2021-07-08
Primary completion
2023-09-29
Completion
2023-09-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Azacitidine Other / unclassified 10 mg Other
Subject Trastuzumab Monoclonal antibody 21 mg Other