Using MRI-Guided Laser Heat Ablation to Induce Disruption of the Peritumoral Blood Brain Barrier … (NCT02372409) | Clinical Trial Compass
TerminatedPhase 2
Using MRI-Guided Laser Heat Ablation to Induce Disruption of the Peritumoral Blood Brain Barrier to Enhance Delivery and Efficacy of Treatment of Pediatric Brain Tumors
Stopped: Low accruals and competing clinical trials
United States6 participantsStarted 2015-08-14
Plain-language summary
By employing a combination of advanced MRI techniques and correlative serum biomarkers of blood brain barrier (BBB) disruption, the investigators plan to develop a powerful, first of its kind clinical algorithm in pediatrics whereby the investigators can measure and identify the window of maximal BBB disruption post MLA to 1) allow for an alternative to surgery in incompletely resected tumors, 2) allow for optimal chemotherapeutic dosing to achieve the greatest benefits and the least systemic side effects and 3) distinguish subsequent tumor progression from long-term MLA treatment effects. Preliminary data in adult imaging studies have shown that the BBB disruption lasts for several weeks following treatment before returning to a low baseline. This pilot therapeutic study will provide preliminary validation in pediatric patients.
Who can participate
Age range
3 Years – 21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
ARM A
* Presumed pediatric gliomas (grades I-IV) on MRI that are determined to be candidates for MLA by the treating neurosurgeon
* Age 3 to ≤ 21
* Karnofsky/Lansky performance status ≥ 60%
ARM B
* Recurrent pediatric brain tumors determined candidates for MLA as determined by the treating neurosurgeon.
* Unequivocal evidence of tumor progression by MRI
* There must be an interval of at least 12 weeks from the completion of radiotherapy to study registration except if there is unequivocal evidence for tumor recurrence per RANO criteria. When the interval is less than 12 weeks from the completion of radiotherapy, the use of PET scan is allowed to differentiate between evidence of tumor recurrence and pseudoprogression.
* Recurrent lesions with dimension and contour that are determined by the treating neurosurgeon to be appropriate for MLA.
* Age 3 to ≤ 21
* Karnofsky/Lansky performance status ≥ 60%
* Adequate cardiac function as determined by a shortening fraction ≥ 27% or left ventricular ejection fraction ≥ 50% by echocardiogram within the past 1 year prior to registration.
* Prior anthracycline therapy does not exceed 200 mg/m\^2 total cumulative dose.
* Adequate bone marrow and hepatic function as defined below (must be within 7 days of MLA):
* Absolute neutrophil count (ANC) ≥ 1000/mcl (G-CSF is allowed)
* Platelets ≥ 100 K/cumm
* Hemoglobin ≥ 9 g/dL (pRBC transfusion +/- ESA are allowed)
* ALT ≤ 3 x ULN
* AST ≤ 3 x ULN
* ALP ≤ 3 x ULN…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Arm A Only: Number of Participants With Progression-free Survival (PFS)
Timeframe: Up to 5 years from date of registration (median length of follow-up, full range 196 days-1801 days)
2
Arm A Only: Overall Survival (OS) as Measured by Number of Participants Alive at 5 Years
Timeframe: Up to 5 years from date of registration (median length of follow-up, full range 196 days-1801 days)
3
Arm B Only: Number of Participants With Progression-free Survival (PFS)