Infusion of 5-Azacytidine (5-AZA) Into the Fourth Ventricle in Patients With Recurrent Posterior Fossa Ependymoma



Status:Recruiting
Healthy:No
Age Range:1 - 80
Updated:3/7/2019
Start Date:February 8, 2019
End Date:July 1, 2020
Contact:Bangning Yu, MD, PhD
Email:Bangning.Yu@uth.tmc.edu
Phone:713-500-7363

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Infusion of 5-Azacytidine (5-AZA) Into the Fourth Ventricle or Resection Cavity in Children and Adults With Recurrent Posterior Fossa Ependymoma: A Phase I Study

This study seeks to determine the optimum dose frequency of 5-Azacytidin (5-AZA) infusions
into the fourth ventricle of the brain. The study's primary objective is to establish the
maximum tolerated dose for infusions of 5-Azacytidine into the fourth ventricle in patients
with recurrent ependymoma. The study's secondary objective is to assess the antitumor
activity of 5-Azacytidine infusions into the fourth ventricle based upon imaging studies and
cytology.


Inclusion Criteria:

- Diagnosis: Patients with histologically verified ependymoma, with recurrence or
progression anywhere in the brain and/or spine. Patients are also eligible if they
have refractory disease, which will be defined as residual tumor which has not been
completely cleared despite prior treatments. To be eligible, patients' disease must
have originated in the posterior fossa of the brain

- Patient must have either measurable or evaluable tumor as assessed by MRI of the brain
and total spine

- An implanted catheter in the fourth ventricle or posterior fossa tumor cavity attached
to a ventricular access device or agreement to have one placed.

- A minimum of 7 days between last dose of systemic chemotherapy and/or radiation
therapy and first infusion of 5-AZA into fourth ventricle

- Life expectancy of at least 12 weeks in the opinion of the principal investigator

- Lansky score of 50 or greater if ≤16 years of age or Karnofsky score of 50 or greater
if > 16 years of age

- Existing neurological deficits must have been stable for a minimum of 1 week prior to
study enrollment

- Patients must have recovered from the acute toxic effects of all prior anticancer
chemotherapy

- Adequate bone marrow function defined by peripheral absolute neutrophil count (ANC) ≥
500/μL, platelet count ≥ 50,000/μL (transfusion independent), and hemoglobin ≥ 9.0
gm/dL (may receive RBC transfusions)

- Patient or patient's legal representative, parent(s), or guardian able to provide
written informed consent.

Exclusion Criteria:

- Enrolled in another treatment protocol

- Has received another investigational or chemotherapy agent or radiation therapy within
7 days prior to 5-AZA infusion into the fourth ventricle

- Evidence of untreated infection

- Pregnant or lactating women
We found this trial at
1
site
7000 Fannin St
Houston, Texas 77030
(713) 500-4472
Phone: 713-500-7363
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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Houston, TX
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