Stopped: Low accruals and competing clinical trials
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.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
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)
Arm B Only: Number of Participants With Progression-free Survival (PFS)
Timeframe: At 6 months