Targeting Pediatric Brain Tumors and Relapsed/Refractory Solid Tumors With Sodium Glucose Cotransporter 2 Inhibitors (SGLT2i)
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.
Arms & interventions
- DrugDapagliflozin
Commercially available
- DrugCarmustine
Standard of care
- DrugTopotecan
Standard of care
- DrugCyclophosphamide
Standard of care
Outcome measures
Primary
Number and type of adverse events experienced by participants
-Adverse events will be graded by CTCAE (version 5.0).
Time frame: From start of treatment through 30 days after last day of dapagliflozin treatment (estimated to be 4 months)
Secondary
Change in blood glucose
Time frame: From baseline through end of treatment (estimated to be 3 months)
Change in ketones
Time frame: From baseline through end of treatment (estimated to be 3 months)
Change in HbA1c
Time frame: From baseline through end of treatment (estimated to be 3 months)
Changes in fructosamine
Time frame: From baseline through end of treatment (estimated to be 3 months)
Changes in c-peptide
Time frame: From baseline through end of treatment (estimated to be 3 months)
Changes in glucagon
Time frame: From baseline through end of treatment (estimated to be 3 months)
Imaging-guided tumor response assessment
Time frame: From pre-therapy to post-12 weeks of therapy
Tumor response rate as measured by number of participants with complete response or partial response
Time frame: From pre-therapy to post-12 weeks of therapy
Eligibility criteria
Study locations (1)
Washington University School of Medicine/St. Louis Children's Hospital
St Louis, Missouri, 63110