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Anti-tumor antibiotic
Focused Ultrasound + Chemotherapy for Pediatric Brain Tumor
Phase 1 & 2
Recruiting
Research Sponsored by InSightec
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial will look at using ultrasound and chemo to treat a brain tumor in kids.
Who is the study for?
This trial is for pediatric patients aged 5-21 with DIPG who have completed radiation therapy within the last 4-12 weeks and show no signs of necrosis or hemorrhage. They must be neurologically stable, not on increasing steroids, and haven't had brain surgery in the past two weeks. Exclusions include hypertension, contraindications to Doxorubicin, metastatic disease, bleeding disorders, vasculopathy, immunosuppression (except certain steroids), active seizures despite treatment, known sensitivities to specific contrast agents or drugs like Avastin.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of disrupting the blood-brain barrier using Exablate Focused Ultrasound (Model 4000 Type2.0/2.1) combined with Doxorubicin chemotherapy for treating pediatric DIPG—a type of brain tumor.See study design
What are the potential side effects?
Potential side effects may include those related to Doxorubicin such as hair loss, nausea/vomiting, mouth sores; heart damage; low blood counts leading to infection risk; and those from focused ultrasound like discomfort at the target site or headaches due to BBB disruption.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse Events
Secondary outcome measures
Blood Brain Barrier Disruption (BBBD)
Other outcome measures
Progression Free Survival (PFS)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Blood Brain Barrier Disruption (BBBD)Experimental Treatment2 Interventions
Exablate MR Guided Focused Ultrasound for Blood Brain Barrier Disruption with Doxorubicin for treating pediatric patients with DIPG
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doxorubicin
2012
Completed Phase 3
~7940
Find a Location
Who is running the clinical trial?
InSightecLead Sponsor
89 Previous Clinical Trials
3,704 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had seizures that medication couldn't control for at least 4 weeks.I am not on immunosuppression, except for steroids for brain swelling.My scans after radiation show no signs of tissue death or bleeding that would prevent focused ultrasound treatment.I am currently on Avastin therapy or taking higher doses of steroids.I might need trastuzumab treatment during the study.My blood pressure is high for my age.I have a bleeding disorder or my tumor has bled on its own.I experience symptoms like headaches or vision changes.My cancer has spread to other parts of my body.I cannot take Doxorubicin due to health reasons.I have been in early-stage trials for cancer treatment before.I am not currently on blood thinners or medications that increase bleeding risk.I am between 5 and 21 years old.I may need medications that affect how my body processes drugs during the study.I have a blood vessel disorder in my brain or body.It's been over 2 weeks since my brain surgery, and I've fully recovered without any neurological issues.I am allergic to DEFINITY® or its ingredients like polyethylene glycol.I have received full doses of certain chemotherapy drugs before.I finished my radiation therapy between 4 to 12 weeks ago.My neurological condition has been stable or getting better for the last week.My kidney function is significantly below normal for my age.My steroid dose has been stable or decreasing for the last week.I have been diagnosed with a brain tumor known as DIPG.
Research Study Groups:
This trial has the following groups:- Group 1: Blood Brain Barrier Disruption (BBBD)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals aged 75 or above accepted for this investigation?
"This study requires that participants are aged between 5 and 21. There is a total of 82 trials for minors, while 351 clinical studies exist to assist elderly patients."
Answered by AI
Are there any vacancies available in the trial for participants?
"Unfortunately, based on the information detailed on clinicaltrials.gov, this trial is no longer looking for participants. This research project first appeared online on December 1st 2022 and was last updated November 18th 2022; however, 408 other studies are currently enrolling eligible volunteers."
Answered by AI
Is enrollment for this medical experiment currently available?
"Applicable candidates must have neoplasms within the brain and be between 5-21 years old. Approximately 10 individuals are needed for this research endeavour."
Answered by AI
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