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

Completed · Early Phase 1

Conditions studied: Brain Tumor Recurrent

In brief

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.

Key facts

Study ID

NCT02940483

Run by

The University of Texas Health Science Center, Houston

People needed

6

Starts

2017-02-01

Expected to finish

2018-11-28

Last updated by the study team

2018-11-30

Who can join

Age: 1 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 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.

You may not qualify if…

• 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

Where it is running

• UTHealth & Children's Memorial Hermann Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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