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

• Status: Completed
• Trial end date: 2018-11-28
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston
• Treatments: Azacitidine

Criteria

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 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-Azacytidine infusion into the fourth ventricle.

• Evidence of untreated infection

• Pregnant of lactating women