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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline(before start of treatment),end of treatment (7 days after treatment)

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 days after treatment

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of patients with new neurological deficits

Secondary outcome measures

Change in disease progression as assessed by lumbar CSF cytology

Change in disease progression as assessed by magnetic resonance imaging (MRI)

Trial Design

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor

904 Previous Clinical Trials

320,950 Total Patients Enrolled

2 Trials studying Ependymoma

15 Patients Enrolled for Ependymoma

David I Sandberg, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston

2 Previous Clinical Trials

16 Total Patients Enrolled

1 Trials studying Ependymoma

9 Patients Enrolled for Ependymoma

Media Library

5-Azacytidine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT04958486 — Phase < 1

Ependymoma Research Study Groups: Treatment

Ependymoma 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must potential participants meet to be eligible for this research initiative?

"This clinical trial is recruiting around 10 participants with ependymoma between the ages of 1 Year and 80. To be eligible, you must meet these criteria."

Answered by AI

What therapeutic conditions can be treated with a 5-Azacytidine and trastuzumab infusion?

"Complete blood count is typically managed with 5-Azacytidine and trastuzumab infusion. These treatments can also provide benefit in cases of induction chemotherapy, leukemia, myelocytic, acute forms of illness, or those displaying a high risk for recurrence."

Answered by AI

What other evidence exists that suggests 5-Azacytidine and trastuzumab infusion are effective treatments?

"Currently, there are 363 medical studies concerning the infusion of 5-Azacytidine and trastuzumab. Out of these trials, 81 have reached Phase 3 status. The majority of sites that offer this treatment are in Seattle, Washington; however, a total of 20117 locations worldwide provide this therapy."

Answered by AI

How many individuals have opted to participate in this experiment?

"Affirmative. As per information hosted on clinicaltrials.gov, this medical study is currently seeking out participants. It was first published on July 8th 2021 and updated for the last time on June 30th 2022; with a goal of recruiting 10 people from 1 location."

Answered by AI

Are there any vacancies still available for this medical experiment?

"As indicated on clinicaltrials.gov, this trial is currently sourcing participants. The study was first posted in July 8th 2021 and the most recent update occurred June 30th 2022."

Answered by AI

Does this trial include individuals over the age of 25 in its recruitment process?

"This investigation allows patients between 1 year old and 80 years of age to participate. There are 70 trials for minors, while elderly people over 65 have 363 opportunities available."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Combination Intraventricular Chemotherapy Pilot Study: 5-Azacytidine (5-AZA) and Trastuzumab Infusions Into the Fourth Ventricle or Resection Cavity in Children and Adults With Recurrent or Residual Posterior Fossa Ependymoma

David Ilan Sandberg 2021. "Combination Intraventricular Chemotherapy Pilot Study: 5-Azacytidine (5-AZA) and Trastuzumab Infusions Into the Fourth Ventricle or Resection Cavity in Children and Adults With Recurrent or Residual Posterior Fossa Ependymoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04958486.

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