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Histone Deacetylase Inhibitor

Panobinostat Infusion for Medulloblastoma

Phase < 1

Recruiting

Led By David IIan 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

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 red blood cells(RBC) transfusions)

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 4 months post intervention

Awards & highlights

Study Summary

This trial is testing whether it's safe to give patients with brain cancer an infusion of panobinostat directly into their brain, and whether the treatment has any effect on the cancer.

Who is the study for?

This trial is for children and adults with recurrent medulloblastoma, a type of brain cancer. Participants must have stable neurological conditions, adequate liver function (with consultations if needed), and agree to an implanted catheter for treatment delivery. Pregnant or lactating women, those on other trials, or recently treated with chemotherapy/radiation are excluded.Check my eligibility

What is being tested?

The study tests the safety and tumor-fighting ability of panobinostat (MTX110) infusions directly into the fourth ventricle or resection cavity in the brain. The effectiveness will be monitored through MRI scans and cerebrospinal fluid analysis.See study design

What are the potential side effects?

While not explicitly listed here, potential side effects may include local reactions at infusion sites, changes in liver enzymes indicative of liver damage, cardiac issues like prolonged QT interval which can affect heart rhythm, blood disorders due to bone marrow suppression such as low white cell counts increasing infection risk.

Eligibility Criteria

Inclusion Criteria

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

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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, regardless of my age.

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 months post intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 months post intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months post intervention 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 with grade 3 through grade 5 new neurological adverse events that are related to study drug

Secondary outcome measures

Change in disease progression as measured by an MRI

Change in disease progression as measured by lumbar CSF cytology

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment with MTX110Experimental Treatment1 Intervention

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor

903 Previous Clinical Trials

320,972 Total Patients Enrolled

Midatech Pharma plcUNKNOWN

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

Media Library

MTX110 (Histone Deacetylase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04315064 — Phase < 1

Medulloblastoma Research Study Groups: Treatment with MTX110

Medulloblastoma Clinical Trial 2023: MTX110 Highlights & Side Effects. Trial Name: NCT04315064 — Phase < 1

MTX110 (Histone Deacetylase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04315064 — Phase < 1

Frequently Asked Questions

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

How many participants have so far enrolled in this clinical trial?

"Affirmative. The clinicaltrials.gov website indicates that this medical study, which was originally posted on April 21st 2020, is seeking out participants. Five subjects are needed to be recruited from one specific site."

Answered by AI

Are there any opportunities to enroll in this clinical investigation at the moment?

"Affirmative. According to clinicaltrials.gov, this medical expriment is currently recruiting volunteers - it was originally launched on April 21st 2020 and has been updated recently in June 30th 2022. The trial requires 5 participants from a single location."

Answered by AI

Is the age threshold for this clinical research higher than seventy years?

"The requirements for this study necessitate that participants are between 1 and 80 years old. Additionally, there exist 70 medical trials directed at younger patients (under 18) and 13 specifically designed to treat the elderly population (over 65)."

Answered by AI

Is my profile compatible with the requirements of this research project?

"This trial is accepting a maximum of 5 patients with medulloblastoma between infancy and advanced age. To be considered eligible, contenders must meet the following prerequisites: A medical diagnosis of recurrence or progression involving any part of the brain/spine, observable or assessable tumor via MRI scan; catheter placed in fourth ventricle region connected to access device OR consenting to have one inserted, 7 days gap between last anticancer chemo dose & first infusion into fourth ventricle, life expectancy exceeding 12 weeks according to PI judgement; Lansky score ≥50 (when ≤16 yrs old) / Karnofsky"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Infusion of Panobinostat (MTX110) Into the Fourth Ventricle in Children and Adults With Recurrent Medulloblastoma

David Ilan Sandberg 2020. "Infusion of Panobinostat (MTX110) Into the Fourth Ventricle in Children and Adults With Recurrent Medulloblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04315064.

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