Safety Study of Dapagliflozin with Chemotherapy to Treat Children and Young Adults with Recurrent Brain Tumors and Relapsed or Refractory Solid Tumors

What this Trial Is About

Researchers are evaluating the safety and potential effectiveness of dapagliflozin, a sodium glucose cotransporter 2 inhibitor, combined with standard chemotherapy for treating pediatric patients with recurrent brain tumors and relapsed or refractory solid tumors. This pilot Phase Ib study aims to determine if dapagliflozin is well-tolerated and safe in this patient group while also assessing its impact on tumor markers through its metabolic effects. Participants will receive dapagliflozin orally once daily alongside standard chemotherapy regimens such as carmustine or a combination of topotecan and cyclophosphamide. The dapagliflozin dose starts at 5 mg daily for up to 12 weeks, with some patients having the dose increased to 10 mg after initial treatment, following consultation with a study endocrinologist. Chemotherapy cycles last 21 days for those on topotecan plus cyclophosphamide. During the study, participants will be monitored for adverse events from treatment start through 30 days after stopping dapagliflozin, approximately 4 months. Researchers will assess changes in blood glucose, ketones, HbA1c, fructosamine, c-peptide, and glucagon levels over about 3 months. Tumor response will be evaluated using imaging before and after 12 weeks of therapy. The study is expected to continue until mid-2031 with multiple safety and efficacy assessments throughout.

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