Clinical trial NCT05521984: Targeting Pediatric Brain Tumors and Relapsed/Refractory Solid Tumors With Sodium Glucose Cotransporter 2 Inhibitors (SGLT2i)
Official title: Targeting Pediatric Brain Tumors and Relapsed/Refractory Solid Tumors With Sodium Glucose Cotransporter 2 Inhibitors (SGLT2i)
Conditions: Pediatric Brain Tumor
Pediatric Solid Tumor
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.
Interventions:
description: Commercially available
name: Dapagliflozin
type: Drug
description: Standard of care
name: Carmustine
type: Drug
description: Standard of care
name: Topotecan
type: Drug
description: Standard of care
name: Cyclophosphamide
type: Drug
Study arms:
design_group_description: * Dapagliflozin will be initiated by mouth once daily at the same time as standard of care chemotherapy (carmustine).<br/>* Dapagliflozin 5 mg by mouth once daily on days 1-84 (duration of study)<br/>* All patients will stop taking dapagliflozin after 12 weeks of treatment.
design_group_title: Brain Cancer: Dapagliflozin + Standard of Care Chemotherapy (Ages 6-10)
design_group_type: Experimental
design_group_description: * Dapagliflozin will be initiated by mouth once daily at the same time as standard of care chemotherapy (carmustine).<br/>* Dapagliflozin will be initiated at 5 mg by mouth once daily, days 1-4 (2 weeks)<br/>* Dapagliflozin will be escalated to 10 mg by mouth once daily for the remaining 10 weeks (after consultation with study endocrinologist)<br/>* All patients will stop taking dapagliflozin after 12 weeks of treatment.
design_group_title: Brain Cancer: Dapagliflozin + Standard of Care Chemotherapy (Ages 11-21)
design_group_type: Experimental
design_group_description: * Dapagliflozin will be initiated by mouth once daily at the same time as standard of care chemotherapy (topotecan + cyclophosphamide).<br/>* Dapagliflozin 5 mg by mouth once daily on days 1-84 (duration of study)<br/>* All patients will stop taking dapagliflozin after 12 weeks of treatment.<br/>* Each cycle is 21 days.
design_group_title: Solid Tumor Cancer: Dapagliflozin + Standard of Care Chemotherapy (Ages 6-10)
design_group_type: Experimental
design_group_description: * Dapagliflozin will be initiated by mouth once daily at the same time as standard of care chemotherapy (topotecan + cyclophosphamide).<br/>* Dapagliflozin will be initiated at 5 mg by mouth once daily, days 1-4 (2 weeks)<br/>* Dapagliflozin will be escalated to 10 mg by mouth once daily for the remaining 10 weeks (after consultation with study endocrinologist)<br/>* All patients will stop taking dapagliflozin after 12 weeks of treatment.<br/>* Each cycle is 21 days.
design_group_title: Solid Tumor Cancer: Dapagliflozin + Standard of Care Chemotherapy (Ages 11-21)
design_group_type: Experimental
Sponsor: Washington University School of Medicine
Collaborators: Childrens Discovery Institute
Drug name mappings:
name: 环磷酰胺
lang: CN
name: Cyclophosphamide
lang: EN
name: シクロホスファミド水和物
lang: JP
name: 卡莫司汀
lang: CN
name: Carmustine
lang: EN
name: カルムスチン
lang: JP
name: 达格列净
lang: CN
name: Dapagliflozin
lang: EN
name: ダパグリフロジンプロピレングリコール水和物
lang: JP
name: 盐酸托泊替康
lang: CN
name: Topotecan Hydrochloride
lang: EN