Actively Recruiting
Targeting Pediatric Brain Tumors and Relapsed/Refractory Solid Tumors With Sodium Glucose Cotransporter 2 Inhibitors (SGLT2i)
Led by Washington University School of Medicine · Updated on 2026-04-02
20
Participants Needed
1
Research Sites
430 weeks
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
C
Children's Discovery Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Targeting Pediatric Brain Tumors and Relapsed/Refractory Solid Tumors With Sodium Glucose Cotransporter 2 Inhibitors (SGLT2i)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of a recurrent primary brain tumor with no curative therapy available or relapsed/refractory solid tumor with no curative option and past second line of therapy
- Measurable disease defined by pediatric RANO criteria for brain tumors or RECIST 1.1 criteria for solid tumors
- Life expectancy greater than 12 weeks
- Prior treatment with radiation, chemotherapy, or both is allowed
- Age between 6 and 21 years inclusive
- Ability to swallow whole pills
- Normal bone marrow and organ function including leukocytes 2 3,000/mcL, absolute neutrophil count 2 1,500/mcL, platelets 2 100,000/mcL
- Total bilirubin C= 1.5 x institutional upper limit of normal (IULN)
- AST(SGOT)/ALT(SGPT) C= 3.0 x IULN
- Creatinine C= IULN or creatinine clearance 2 60 mL/min/1.73 m�b2 for elevated creatinine
- Normal room air oxygenation; if less than 97%, DLCO must be greater than 80%
- Karnofsky or Lansky performance score of at least 60
- Patients of childbearing potential and partners must agree to use two forms of contraception including one barrier method
- Ability and willingness to sign informed consent or have legal representative consent
You will not qualify if you...
- Current or prior treatment with SGLT2 inhibitors or thiazolidinedione
- Current use of high dose dexamethasone above 4 mg/day; must be on stable or decreasing low dose before starting dapagliflozin
- History of other malignancy except those treated over 2 years ago with no disease or localized skin squamous/basal cell carcinoma
- Type 1 diabetes or current insulin treatment
- History of stroke or transient ischemic attack within the last 5 years
- HbA1c above 8.5%
- Receiving other investigational agents
- History of allergic reactions to dapagliflozin or similar compounds
- Uncontrolled illnesses such as active infections, symptomatic heart failure, unstable angina, arrhythmia, peripheral arterial disease, ketoacidosis, severe kidney disease (eGFR < 30 mL/min/1.73m2), symptomatic hypotension, or frequent urinary or yeast infections
- Pregnant or breastfeeding women; must have negative pregnancy test within 14 days before dapagliflozin
- Patients with HIV with CD4+ counts below 350 cells/mcL or recent AIDS-defining infections within 12 months; effective ART treatment recommended if eligible
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Washington University School of Medicine/St. Louis Children's Hospital
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
A
Andrew Cluster, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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