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

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

4

Participants

Timeline

Start Date

July 8, 2021

Primary Completion Date

September 29, 2023

Study Completion Date

September 29, 2023

Conditions
Fossa Ependymoma
Interventions
DRUG

5-Azacytidine and trastuzumab infusion

Patients will receive once weekly 10 mg intraventricular 5-Azacytidine infusions for six consecutive weeks followed by observation in the infusion suite for a minimum of 30 minutes and once weekly 21 mg intraventricular trastuzumab infusions for six consecutive weeks followed by observation for a minimum of 2 hour after each infusion for the first 2 infusions. During this monitoring period, temperature, blood pressure, heart rate, and oxygen saturation will be measured. Patients will also have a neurological examination performed to observe for neurological changes. All patients will undergo an MRI of the brain and total spine with and without gadolinium within 7 days after the final 5-AZA and trastuzumab infusion to determine treatment response and to assess for any signal changes in the brain or spine caused by the infusions and they will have a 30 day and a 90 day follow-up assessment by telephone or in person for assessment of outcome measures and safety

Trial Locations (1)

77030

The University of Texas Health Science Center at Houston, Houston

All Listed Sponsors
lead

The University of Texas Health Science Center, Houston

OTHER