Brain Tumor Recurrent Clinical Trial
Official title:
Infusion of 5-Azacytidine (5-AZA) Into the Fourth Ventricle or Resection Cavity in Children With Recurrent Posterior Fossa Ependymoma: A Pilot Study
The goal of this clinical research study is to establish the safety of direct administration of 5-Azacytidine into the fourth ventricle of the brain or resection cavity in patients with recurrent posterior fossa ependymoma.
If the participant is eligible to take part in this study, the participant will have surgery
to place a catheter into the Ommaya reservoir. The Ommaya reservoir is a catheter system that
allows drugs to be administered directly to parts of the brain. This catheter will used for
the infusion of 5-Azacytidine directly into the 4th ventricle of the brain, which is 1 or the
4 connected fluid-filled cavities in the brain.
If the study doctor thinks it is necessary, based on the location of the tumor, the tumor may
also be removed while the participant is already under anesthesia just before the catheter is
placed.
Study Drug Administration:
The participant will receive 12 weekly (+/- one day) 10 mg infusions of 5-Azacytidine.
5-Azacytidine will be infused through the Ommaya reservoir catheter directly into the 4th
ventricle of the brain starting at a minimum of 7 days after the catheter placement surgery.
A MRI will be done to confirm adequate cerebrospinal fluid flow. The 5-Azacytidine infusion
will last 2-3 minutes.
If the participant already has an Ommaya catheter, 5-Azacytidine will begin after an MRI has
confirmed adequate cerebrospinal fluid flow.
Study Visits:
Prior to first infusion:
Medical history will be reviewed and any updates to health will be recorded. Physical and
Neurological exam with vital signs will be done. Blood (about 1 teaspoon) will be drawn for
routine test. A lumbar puncture will be done. A MRI scan of the brain and spine will be done
to check the status of the disease.
On the days of the 5-Azacytidine Infusion:
A neurological exam with vital signs will be done. A Ommaya reservoir tap (a catheter is
placed into the Ommaya reservoir to give the 5-Azacytidine infusion.
Cerebrospinal fluid (about 1 teaspoon) will be collected for routine tests.
Within 7 days of completing the Final infusion:
A neurological exam with vital signs will be done. A lumbar puncture will be done. A MRI scan
of the brain and spine will be done to check status of the disease.
Length of Study:
The participant will receive 12 infusions of 5-Azacytidine, as long as the doctor thinks it
is in their best interest. The participant will no longer be able to receive the study drug
if the disease gets worse, if intolerable side effects occur, or if unable to follow study
directions.
This is an investigation study. 5-Azacytidine is FDA approved and commercially available to
be given subcutaneous or into the bloodstream (intravenously) but has never been given in the
4th ventricle of the brain. The infusion of 5-Azacytidine into the 4th ventricle of the brain
is investigational.
Up to 10 patients will be enrolled in this study. All will be enrolled at Children's Memorial
Hermann Hospital
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT02905110 -
Methotrexate and Etoposide Infusions Into the Fourth Ventricle in Children With Recurrent Posterior Fossa Brain Tumors
|
Early Phase 1 |