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Histone Deacetylase Inhibitor
Focused Ultrasound + Panobinostat for Brain Cancer
Phase 1
Waitlist Available
Led By Stergios Zacharoulis, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ages 4-21 years
Subjects with evidence of clinical and/or radiographic progression of Diffuse Midline Glioma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 90 days after the end of the last fus treatment
Awards & highlights
Study Summary
This trial is being done to see if it is safe to open the blood brain barrier in children with brain cancer using focused ultrasound technology, and to administer the oral cancer drug Panobinostat.
Who is the study for?
This trial is for children aged 4-21 with progressive diffuse midline glioma (DMG) who've recovered from prior cancer treatments. They must be able to undergo MRI scans, swallow capsules, and have a stable health condition as assessed by the investigator. Those with spinal DMGs, bleeding disorders, metal implants, or severe systemic diseases are excluded.Check my eligibility
What is being tested?
The study tests if Focused Ultrasound (FUS) can safely open the blood-brain barrier in kids with DMG to enhance Panobinostat delivery to brain tumors. The non-invasive FUS will target up to three areas near the tumor while administering oral Panobinostat.See study design
What are the potential side effects?
Potential side effects include reactions related to opening the blood-brain barrier such as temporary neurological changes or discomfort at sonication sites. Oral Panobinostat may cause digestive issues, fatigue, blood count changes and could affect heart rhythm.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 4 and 21 years old.
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My brain tumor is growing or spreading.
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My tumor in the brain stem or thalamus is confirmed by imaging or has a specific genetic change.
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I can swallow capsules.
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I am taking medication for seizures/epilepsy before my first surgery in the study.
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I am between 4 and 21 years old.
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I am mostly able to care for myself and carry out daily activities.
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I can have an MRI scan with a special dye.
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My liver and kidney functions are normal.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 90 days after the end of the last fus treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 90 days after the end of the last fus treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of adverse events
Secondary outcome measures
6-month Overall Survival (OS6)
6-month Progression Free Survival (PFS6)
Blood brain barrier/Tumor imaging changes
Trial Design
1Treatment groups
Experimental Treatment
Group I: FUS using Oral PanobinostatExperimental Treatment2 Interventions
All patients enrolled in the study will be treated with oral Panobinostat after receiving Focused Ultrasound treatment (FUS) with microbubbles and neuro-navigator-controlled sonication.
Find a Location
Who is running the clinical trial?
Focused Ultrasound FoundationOTHER
15 Previous Clinical Trials
311 Total Patients Enrolled
1 Trials studying Diffuse Intrinsic Pontine Glioma
10 Patients Enrolled for Diffuse Intrinsic Pontine Glioma
Columbia UniversityLead Sponsor
1,438 Previous Clinical Trials
2,448,792 Total Patients Enrolled
Cheng-Chia (Fred) WuLead Sponsor
1 Previous Clinical Trials
10 Total Patients Enrolled
1 Trials studying Diffuse Intrinsic Pontine Glioma
10 Patients Enrolled for Diffuse Intrinsic Pontine Glioma
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 4 and 21 years old.My tumor in the brain stem or thalamus is confirmed by imaging or has a specific genetic change.I am allergic to Panobinostat or similar drugs, or to gadolinium.My brain tumor is growing or spreading.I have a bleeding disorder that cannot be corrected.I have signs of brain swelling or recent bleeding within a tumor.I have a brain blood vessel condition.I currently have an active infection.I have a bleeding disorder or am on blood thinners.My high blood pressure is not controlled by medication.My tumor is bleeding.You have implanted medical devices or metal implants.I am using two effective birth control methods if my partner can get pregnant or if I can get pregnant.You are not pregnant or breastfeeding, and you have had a negative pregnancy test within the past 7 days if you could become pregnant.I am healthy enough for FUS, MRI, and any required anesthesia, as per my doctor.I can swallow capsules.I am taking medication for seizures/epilepsy before my first surgery in the study.I have a condition that makes anesthesia or surgery too risky.I have recovered from side effects of my previous cancer treatments.I am between 4 and 21 years old.It's been over a week since my last non-myelosuppressive cancer treatment.I have recovered from all side effects of my previous cancer treatments.I am mostly able to care for myself and carry out daily activities.I have had a stroke or heart disease in the past.I have a spinal diffuse midline glioma.Your blood counts must be within certain limits.I cannot undergo general anesthesia due to a medical condition.I can have an MRI scan with a special dye.I have been on a stable or decreasing dose of steroids and anti-seizure medication for at least 1 week.My liver and kidney functions are normal.You need to have an EKG test within 7 days before joining the study.
Research Study Groups:
This trial has the following groups:- Group 1: FUS using Oral Panobinostat
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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