An Early Phase 1 interventional study of 5-Azacytidine and trastuzumab infusion in Fossa Ependymoma, sponsored by The University of Texas Health Science Center, Houston. Completed at 1 site in United States. Open to participants aged 1 Year to 80 Years. Per ClinicalTrials.gov, last updated 2025-03-03.
Sponsored by The University of Texas Health Science Center, Houston · Early Phase 1, Interventional, and Treatment
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.
180 studies on the registry are indexed under Ependymoma; 35 are open to participants now.
This study's enrollment of 4 is below the median of 30 across 149 interventional studies indexed under Ependymoma.
Browse Ependymoma studies →The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Number of patients with new neurological deficits
A new neurological deficit will be defined as new cranial neuropathy, change in level of consciousness, motor weakness, gait change or cerebellar finding (ataxia, dysmetria, dysdiadochokinesis) that is attributed by treating physicians to infusions. New neurological deficits graded as Grade 3 or higher after infusions will be defined as serious adverse events (SAE's)
Time frame: 7 days after treatment
Change in disease progression as assessed by magnetic resonance imaging (MRI)
Time frame: Baseline(before start of treatment),end of treatment (7 days after treatment)
Change in disease progression as assessed by lumbar CSF cytology
Time frame: Baseline(before start of treatment),end of treatment (7 days after treatment)
Plan to share: No
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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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The University of Texas Health Science Center, Houston