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Targeting Pediatric Brain and Solid Tumors with Dapagliflozin

This study is looking at the safety of adding dapagliflozin to standard treatments like Carmustine, Topotecan, and Cyclophosphamide for children and young adults (ages 6 to 21) with recurrent brain tumors or solid tumors that have come back or not responded to previous treatments. The main goal is to see if dapagliflozin is safe and well-tolerated in this group of patients. Researchers also hope that dapagliflozin, which is a commercially available drug, might help standard chemotherapy work better by affecting how tumor cells use energy. The study plans to enroll about 20 participants. The current status of the study is unclear.

Study design
This is a pilot Phase Ib study, which means it's an early study focused on safety. It plans to enroll about 20 participants.
What's involved
Participants will receive dapagliflozin in addition to standard treatments. Adverse events will be monitored from the start of treatment through 30 days after the last dose of dapagliflozin, estimated to be about 4 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for adverse events for 30 days after their last dose of dapagliflozin, which is estimated to be about 4 months after starting treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05521984

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

Recruiting
PHASE1Ages 6–21InterventionalTreatment
Washington University School of Medicine
~20 participants
Updated 2026-06-10 on ClinicalTrials.gov
What's tested:DapagliflozinCarmustineTopotecanCyclophosphamide

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number and type of adverse events experienced by participants
Measured over From start of treatment through 30 days after last day of dapagliflozin treatment (estimated to be 4 months)

Conditions

Pediatric Brain Tumor
Pediatric Solid Tumor

Explore related trials

Brain NeoplasmNeuroblastomaSarcomaSolid NeoplasmWilms Tumor

NCT05521984

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Washington University School of Medicine/St. Louis Children's Hospital

    St Louis, Missouristudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Andrew Cluster, M.D. · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

Who to contact

Andrew Cluster, M.D.
[email protected]
314-273-1451
Email the study team

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Eligibility criteria

Inclusion

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 Wilms tumor. Other rare solid tumors can be discussed with study chair.
Life expectancy \> 12 weeks.
Prior treatment with radiation alone, chemotherapy alone or combined radiation and chemotherapy is allowed.
Patient is between 6 and 29 years old (inclusive)
Patient is capable of swallowing whole pills
Normal bone marrow and organ function as defined below:
Leukocytes ≥ 3,000/mcL
Absolute neutrophil count ≥ 1,500/mcl
Platelets ≥ 100,000/mcl
Total bilirubin ≤ 1.5 x IULN
AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
Creatinine ≤ IULN OR creatinine clearance ≥ 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
Normal room air oxygenation must be documented. If room air oxygen saturation is less than 97%, a diffusion capacity of carbon monoxide (DLCO) of greater than 80%, must be demonstrated.
Karnofsky or Lansky performance score of ≥ 60
Patients of childbearing potential and their partners must agree to use two forms of acceptable contraception (including one barrier method) prior to study entry and for the duration of study participation. Should a female patient or partner of a male patient become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants. All patients and/or their parents or legal guardians must sign an IRB approved written informed consent document.

Exclusion

Current or previous treatment with SGLT2i or thiazolidinedione.
Current use of high dose dexamethasone (exceeding 4 mg/day). Seven days prior to start of dapagliflozin, patients receiving dexamethasone must be on a stable or decreasing dose (≤ 0.1 mg/kg/day or maximum 4 mg/day). Note that it is preferred that patients not be on dexamethasone during the study.
A history of other malignancy with the exceptions of malignancies for which all treatment was completed at least 2 years before registration with no evidence of disease and locally treated skin squamous or basal cell carcinoma.
Type 1 diabetes or current insulin treatment.
History of stroke or transient ischemic attack (in the last 5 years).
HbA1c \> 8.5%. The rationale is that this is the level that would require addition of insulin. However, insulin use is excluded in this study due to the increased risk of ketoacidosis.
Currently receiving any other investigational agents.
A history of allergic reactions attributed to compounds of similar chemical or biologic composition to dapagliflozin or other agents used in the study.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, peripheral arterial disease, ketoacidosis, severe kidney disease (estimated glomerular filtration rate eGFR \< 30 mL/min/1.73m\^2), symptomatic hypotension, and chronic/frequent urinary tract infections or yeast infections.
Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days prior to first dose of dapagliflozin.
Patients with HIV are eligible unless their CD4+ T-cell counts are \< 350 cells/mcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended.

What this trial measures

  • Number and type of adverse events experienced by participantsFrom start of treatment through 30 days after last day of dapagliflozin treatment (estimated to be 4 months)

    -Adverse events will be graded by CTCAE (version 5.0).