Targeting Pediatric Brain Tumors and Relapsed/Refractory Solid Tumors With Sodium Glucose Cotransporter 2 Inhibitors (SGLT2i)
Washington University School of Medicine
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
- Age range
- 6–21 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Diagnosis of a recurrent primary brain tumor with no curative therapy available OR diagnosis of relapsed/refractory solid tumor with no curative option and has trialed past a second line of therapy. * Measurable disease per the following: * For patients with brain tumors: measurable disease pediatric Response Assessment in Neuro-Oncology Criteria (RANO) criteria * For patients with solid tumors: measurable disease using response evaluation criteria in solid tumors (RECIST 1.1). Includes patients with diagnoses of relapsed or refractory sarcomas, neuroblastoma, and W…
Interventions
- DrugDapagliflozin
Commercially available
- DrugCarmustine
Standard of care
- DrugTopotecan
Standard of care
- DrugCyclophosphamide
Standard of care
Location
- Washington University School of Medicine/St. Louis Children's HospitalSt Louis, Missouri