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Anti-metabolites

5-Azacytidine Infusion for Brain Cancer (5-AZA Trial)

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

Patients with histologically verified ependymoma, with recurrence or progression anywhere in the brain and/or spine

Patients with refractory disease, defined as residual tumor which has not been completely cleared despite prior treatments, originating in the posterior fossa of the brain

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

5-AZA Trial Summary

This trial is testing a new way to give the drug 5-Azacytidine to people with a brain tumor called ependymoma. The goal is to find the best dose and how often to give it.

Who is the study for?

This trial is for patients with a specific brain cancer called recurrent posterior fossa ependymoma. They must have an implanted catheter or agree to one, a life expectancy of at least 12 weeks, stable neurological conditions, and adequate bone marrow function. Pregnant women, those with untreated infections or recent treatments from other trials are excluded.Check my eligibility

What is being tested?

The study tests different dosing frequencies of the drug 5-Azacytidine (5-AZA) infused directly into the fourth ventricle of the brain to find the safest maximum dose and assess its effectiveness against tumor activity through imaging studies.See study design

What are the potential side effects?

While not explicitly listed in your summary, side effects for this type of treatment could include headaches, nausea, infection risk at infusion site, potential blood disorders due to bone marrow involvement and possible worsening of existing neurological deficits.

5-AZA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My ependymoma cancer has come back or gotten worse in my brain or spine.

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My brain tumor in the back of my head hasn't gone away despite treatment.

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I have or agree to get a catheter in my brain for treatment.

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I have recovered from the side effects of my previous cancer treatments.

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My blood tests show enough neutrophils, platelets, and hemoglobin.

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I am mostly active and can do things for myself.

5-AZA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks 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 participants who experienced dose-limiting toxicity (DLT)

Secondary outcome measures

Number of participants with disease progression as assessed by magnetic resonance imaging (MRI)

5-AZA Trial Design

3Treatment groups

Experimental Treatment

Group I: group 3Experimental Treatment1 Intervention

5-Azacytidine (5-AZA) group 3: Enrolled patients will undergo surgical placement of a ventricular catheter into the fourth ventricle that will be attached to a subcutaneously placed reservoir. Patients will be divided into 3 dose groups and receive 8 weeks of intraventricular 5-AZA (12 mg) into the fourth ventricle. Patients in Group 3 will receive four 5-AZA infusions every week.

Group II: group 2Experimental Treatment1 Intervention

5-Azacytidine (5-AZA) group 2: Enrolled patients will undergo surgical placement of a ventricular catheter into the fourth ventricle that will be attached to a subcutaneously placed reservoir. Patients will be divided into 3 dose groups and receive 8 weeks of intraventricular 5-AZA (12 mg) into the fourth ventricle. Patients in Group 2 will receive three 5-AZA infusions every week.

Group III: group 1Experimental Treatment1 Intervention

5-Azacytidine (5-AZA) group 1: Enrolled patients will undergo surgical placement of a ventricular catheter into the fourth ventricle that will be attached to a subcutaneously placed reservoir. Patients will be divided into 3 dose groups and receive 8 weeks of intraventricular 5-AZA (12 mg) into the fourth ventricle. Patients in Group 1 will receive two 5-AZA infusions every week.

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor

904 Previous Clinical Trials

320,988 Total Patients Enrolled

2 Trials studying Ependymoma

16 Patients Enrolled for Ependymoma

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

2 Previous Clinical Trials

17 Total Patients Enrolled

1 Trials studying Ependymoma

10 Patients Enrolled for Ependymoma

Media Library

5-Azacytidine (5-AZA) (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT03572530 — Phase 1

Ependymoma Research Study Groups: group 3, group 1, group 2

Ependymoma Clinical Trial 2023: 5-Azacytidine (5-AZA) Highlights & Side Effects. Trial Name: NCT03572530 — Phase 1

5-Azacytidine (5-AZA) (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03572530 — Phase 1

Frequently Asked Questions

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

Are there still spots available in this clinical research program?

"Affirmative. Data on clinicaltrials.gov implies that this research experiment is currently looking for volunteers. Originally posted on February 8th 2019, the study has more recently been updated as of August 17th 2022 and requires 9 participants from a single medical facility to be recruited."

Answered by AI

Is eligibility for the trial limited to adults under 50 years of age?

"This medical trial is enrolling participants that are between 1 year old and 80 years of age."

Answered by AI

Am I eligible to partake in this research?

"To qualify for this clinical study, prospective participants must have ependymoma and fall between 1 year old to 80 years of age. As many as 9 people will be selected in total."

Answered by AI

For what medical purposes is 5-Azacytidine (5-AZA) group 3 generally utilized?

"Group 3 of 5-Azacytidine (5-AZA) is commonly used to treat malignant neoplasms. Dosages may also be prescribed for patients with 20-30% blasts, neutropenia and/or thrombocytopenia, or anemia."

Answered by AI

Are there any existing research endeavors involving group 3 and the medication 5-Azacytidine (5-AZA)?

"Presently, 174 trials associated with 5-Azacytidine (5-AZA) group 3 are in progress. Of these, 32 have advanced to Phase 3 research and the majority of them are concentrated in Saint Louis, Missouri. In total, there are 5671 sites conducting studies on this medication."

Answered by AI

How deleterious is 5-Azacytidine (5-AZA) group 3 for humans?

"Our team at Power has classified the 5-Azacytidine (5-AZA) group 3's safety to be a 1 due to being in its preliminary phase of testing, and thus there is limited data regarding both its efficacy and safety."

Answered by AI

How many participants have been recruited for this research project?

"Affirmative. The information posted on clinicaltrials.gov states that this research is in the process of recruiting participants, having been first published on February 8th 2019 with its most recent update occurring August 17th 2022. 9 patients must be recruited from a single centre."

Answered by AI

Recent research and studies

Pharmacology & TherapeuticsJournal

Genotoxic Therapy and Resistance Mechanism in Gliomas

Lang, Fengchao, Yang Liu, Fu-Ju Chou, and Chunzhang Yang. 2021. “Genotoxic Therapy and Resistance Mechanism in Gliomas”. Pharmacology & Therapeutics. Elsevier BV. doi:10.1016/j.pharmthera.2021.107922.

clinicaltrials.govStudy

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

David Ilan Sandberg 2019. "Infusion of 5-Azacytidine (5-AZA) Into the Fourth Ventricle in Patients With Recurrent Posterior Fossa Ependymoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03572530.

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