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Focused Ultrasound + Etoposide for Brain Tumor
Study Summary
This trial will assess whether FUS can safely open the blood brain barrier, allowing a greater concentration of the drug to reach into the brain tumor, potentially improving response and reducing side effects.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I have been treated with etoposide before.I have seizures that are not controlled by medication.I am not taking any experimental drugs or other cancer treatments.I have had bleeding in my tumor or am at risk of severe brain swelling.I am between 4 and 21 years old.My liver tests are within normal limits.My high blood pressure is not controlled by medication.My blood counts and clotting tests are within normal ranges.I've been on a stable or decreasing dose of steroids and a stable dose of anti-seizure medication for at least a week.I have a bleeding disorder or am on blood thinners.I am allergic to medications similar to etoposide or gadolinium.My condition is spinal cord diffuse midline glioma.I have recovered from side effects of my previous cancer treatments.I have a diagnosed bleeding disorder.I currently have an infection that affects my whole body.I am taking a medication that may cause brain-related side effects.I was hospitalized for COVID-19 recently and need blood thinners.My brain tumor is in the middle part of my brain and has a specific genetic change.I have had a stroke without an obvious cause or signs of stroke in the specific area being targeted for treatment.I am 16 or younger and mostly take care of myself.I am over 16 and can care for myself but may not be able to do active work.I have a history of heart shape issues or irregular heartbeats.My kidney function is within normal ranges, including potassium, magnesium, and creatinine levels.
- Group 1: Focused ultrasound using oral etoposide
- 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
Is the age range for this research restricted to adults under 45?
"This clinical trial is enrolling participants between the ages of four and twenty-one."
Is there an opportunity for me to join this investigation?
"Potential participants in this study must have diffuse intrinsic pontine glioma and be aged between 4 and 21. The trial is accepting around 10 people on a first come, first served basis."
Does this experiment need more participants at present?
"Data published on clinicaltrials.gov reveals that this research endeavour is actively seeking participants, which was first announced March 1st 2023 and last updated February 28th 2023."
How many participants have been recruited to partake in this experiment?
"Indeed, the information provided on clinicaltrials.gov suggests that this medical research is currently in search of participants. This experiment was initially shared online on March 1st 2023 and underwent a revision at the end of February 2023. The team behind this trial plans to enrol 10 patients from one site."
Has the FDA authorized using oral etoposide for Focused ultrasound treatment?
"Our team's assessment of the safety profile of Focused ultrasound using oral etoposide is a 1, as it has only been tested in preliminary clinical trials. As such, there is limited data to support its efficacy and safety."
What goals are researchers looking to achieve with this experiment?
"The primary purpose of this trial is to establish the number of patients who experience successful permeability of their blood-brain barrier. This will be evaluated approximately 90 days after completion of focused ultrasound treatment. Further, a secondary objective includes 3-month overall survival which refers to the period between initial treatment and death from any cause. To measure this outcome, participants will have follow up visits at intervals ranging from every three to six months or until passing away for whatever reason. An additional aim focuses on imaging changes in regards to the BBB/Tumor and identifying severe or serious adverse events with CTCAE version 5.0 noting that throm"
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