RecruitingPhase 1NCT05521984

Targeting Pediatric Brain Tumors and Relapsed/Refractory Solid Tumors With Sodium Glucose Cotransporter 2 Inhibitors (SGLT2i)


Sponsor

Washington University School of Medicine

Enrollment

20 participants

Start Date

Apr 3, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a pilot phase Ib study of the safety of dapagliflozin (in addition to standard of care treatment) for the treatment of pediatric patients with recurrent brain tumors and relapsed/refractory solid tumors. The primary hypothesis is that dapagliflozin is well-tolerated and safe to use in this patient population. The investigators also hypothesize that dapagliflozin will be efficacious as an adjunct to front-line chemotherapy assessed by decreased tumor markers mediated by its pleiotropic metabolic effects.


Eligibility

Min Age: 6 YearsMax Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called sodium iodide symporter (NIS)-based gene therapy in children and young adults with hard-to-treat brain tumors or solid tumors that have come back and have no other curative options. **You may be eligible if...** - You are 6–21 years old - You have a recurrent brain tumor with no curative treatment available, OR a relapsed/refractory solid tumor (such as sarcoma, neuroblastoma, or Wilms tumor) that has failed at least two lines of therapy - You have measurable disease on imaging - You can swallow whole pills - Your life expectancy is more than 12 weeks - Your blood counts and organ function are within acceptable ranges - Your oxygen levels are normal at room air **You may NOT be eligible if...** - You are under 6 or over 21 years old - You cannot swallow pills - Your blood counts or organ function are significantly impaired - Your oxygen saturation is below 97% and your breathing capacity is below 80% Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDapagliflozin

Commercially available

DRUGCarmustine

Standard of care

DRUGTopotecan

Standard of care

DRUGCyclophosphamide

Standard of care


Locations(1)

Washington University School of Medicine/St. Louis Children's Hospital

St Louis, Missouri, United States

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NCT05521984


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