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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
Must not have
Has received another investigational or chemotherapy agent or radiation therapy within 7 days prior to intraventricular chemotherapy infusions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months post intervention
Awards & highlights
No Placebo-Only Group

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.
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.
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
Select...
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.
Select...
My medulloblastoma cancer has come back or gotten worse in my brain or spine.
Select...
I have or agree to get a catheter placed for my brain tumor treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I haven't had any experimental drugs or radiation in the last week.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with grade 3 through grade 5 new neurological adverse events that are related to study drug
Secondary study objectives
Change in disease progression as measured by an MRI
Change in disease progression as measured by lumbar CSF cytology

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: Treatment with MTX110Experimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
949 Previous Clinical Trials
345,020 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
~1 spots leftby Dec 2025
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