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Infusion of 5-Azacytidine (5-AZA) Into the Fourth Ventricle in Patients With Recurrent Posterior Fossa Ependymoma | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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

NCT03572530•The University of Texas Health Science Center, Houston

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

1 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Key Dates

Start Date

February 8, 2019

Primary Completion Date

November 24, 2020

Completion Date

November 24, 2020

Last Updated

April 8, 2025

Enrollment

ACTUAL participants

Conditions

Recurrent Ependymoma

Interventions

5-Azacytidine (5-AZA) group 1

DRUG

5-Azacytidine (5-AZA) group 2

DRUG

5-Azacytidine (5-AZA) group 3

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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