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Focused Ultrasound + Panobinostat for Brain Cancer
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: FUS using Oral Panobinostat
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
Does this clinical trial permit participation from individuals who are senior citizens?
"Participants between the ages of 4 and 21 are eligible to join this clinical trial."
Does this experiment involve any groundbreaking research?
"To date, 14 independent clinical trials for Focused ultrasound with neuro-navigator-controlled sonication have been launched in 95 cities spread across 32 nations. The pioneer study was bankrolled by Secura Bio, Inc., and featured 18 participants; it ended its Phase 1 drug approval stage in 2010. Since then, 72 more studies have taken place."
Could you discuss any previous research on using neuro-navigator-controlled sonication with Focused Ultrasound?
"Currently, 14 trials for Focused ultrasound with neuro-navigator-controlled sonication are running. Not one of those is in Phase 3 yet. Although the main hub for these studies appears to be New york City, 201 total locations across America are participating in this research effort."
Do I meet the prerequisites to join this investigation?
"In order to be considered for this clinical trial, participants must have a diagnosis of diffuse intrinsic pontine glioma and belong within the age group 4-21. Currently 3 individuals are required to take part in the research program."
What safety protocols have been established for Focused Ultrasound with neuro-navigator-controlled sonication?
"As this is an early stage Phase 1 trial, there are only minimal data supporting the safety and efficacy of Focused ultrasound with neuro-navigator-controlled sonication; thus it received a score of 1."
Are there any opportunities remaining to participate in this research endeavor?
"Clinicaltrials.gov confirms that this medical research project is no longer taking on participants; it was initially listed on July 28, 2021 and its last update happened February 3rd 2022. Even though participation in the study has now closed, there are 378 alternative trials presently searching for volunteers."
How many participants are eligible to join this research endeavor?
"No longer in the process of searching for applicants, this medical study was initially advertised on July 28th 2021 and edited as recently as February 3rd 2022. For those looking for alternative clinical trials, there are now 364 studies seeking diffuse intrinsic pontine glioma patients and 14 research projects recruiting participants to test Focused ultrasound with neuro-navigator-controlled sonication."
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