Clinical Trial Details
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NCT02940483 : Infusion of 5-Azacytidine (5-AZA) Into the Fourth Ventricle in Children With Recurrent Posterior Fossa Ependymoma
PhaseEarly Phase 1
AgesMin: 1 Year Max: 21 Years
Inclusion Criteria:

- Diagnosis: Patients with histologically verified ependymoma, with recurrence or
progression involving anywhere in the brain and/or spine. 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-Azacytidine into fourth ventricle.

- Life expectancy of at least 12 weeks in the opinion of the PI

- 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

- 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-Azacytidine infusion into the fourth ventricle.

- Evidence of untreated infection

- Pregnant of lactating women
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