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Anti-metabolites

Chemotherapy for Ependymoma

Phase < 1
Recruiting
Led By David I Sandberg, MD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A minimum of 2 weeks between last dose of any other systemic chemotherapy and first infusion of 5-azacytidine or trastuzumab into fourth ventricle
Lansky score of 50 or greater if ≤16 years of age or Karnofsky score of 50 or greater if > 16 years of age
Must not have
Evidence of untreated infection
Patients with disease that is completely resectable
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days after treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new cancer treatment that involves infusing two drugs into the brain. The goal is to see if it is safe and if it can help shrink tumors.

Who is the study for?
This trial is for children and adults with a type of brain cancer called posterior fossa ependymoma that has come back or didn't go away after treatment. They must have an implanted catheter in the brain, stable neurological conditions, good enough bone marrow function, normal heart (unless cleared by cardiology), kidney and liver functions, and not be pregnant or on other clinical trials.
What is being tested?
The study tests the safety and effectiveness of infusing two drugs directly into the brain: 5-Azacytidine (5-AZA) and Trastuzumab. It aims to see if these drugs can shrink tumors or slow their growth when delivered straight to where they are located in patients with recurrent ependymoma.
What are the potential side effects?
Potential side effects may include reactions at the infusion site within the brain, changes in blood counts leading to increased risk of infections or bleeding, fatigue from low red blood cell levels, as well as possible heart or liver issues which will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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It's been at least 2 weeks since my last chemotherapy before starting 5-azacytidine or trastuzumab.
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I am mostly active and can do things for myself, regardless of my age.
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My cancer started in the back part of my brain and is not responding to treatment.
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My blood tests show enough neutrophils, platelets, and hemoglobin.
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I have recovered from the side effects of my previous cancer treatments.
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I have or agree to get a catheter in my brain for treatment.
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My ependymoma cancer has come back or gotten worse in my brain or spine.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an infection that hasn't been treated.
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My cancer can be entirely removed with surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days after treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days after treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of patients with new neurological deficits

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
949 Previous Clinical Trials
345,015 Total Patients Enrolled
David I Sandberg, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
2 Previous Clinical Trials
16 Total Patients Enrolled

Media Library

5-Azacytidine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT04958486 — Phase < 1
Brain Tumor Research Study Groups: Treatment
Brain Tumor Clinical Trial 2023: 5-Azacytidine Highlights & Side Effects. Trial Name: NCT04958486 — Phase < 1
5-Azacytidine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04958486 — Phase < 1
~2 spots leftby Dec 2025
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