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SGLT2 Inhibitors for Pediatric Brain Cancer

Phase 1
Recruiting
Led By Andrew Cluster, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through completion of treatment for all enrolled patients (estimated to be 39 months)
Awards & highlights

Study Summary

This trial is testing if a new diabetes medication is safe and effective for treating brain tumors in children.

Who is the study for?
This trial is for children and young adults aged 6-21 with recurrent primary brain tumors, who have tried other treatments like radiation or chemotherapy. They must have a life expectancy over 12 weeks, stable vital signs, and normal organ function. Participants need to agree to use contraception if they can have children.Check my eligibility
What is being tested?
The study tests the safety of Dapagliflozin (a diabetes drug) in pediatric brain tumor patients undergoing chemotherapy. It's an early-phase trial where everyone gets the same treatment to see how well they tolerate it.See study design
What are the potential side effects?
Potential side effects include those typical of diabetes medications like Dapagliflozin such as dehydration, low blood sugar levels, urinary tract infections, and possible allergic reactions. Chemotherapy with Carmustine may cause nausea, fatigue, hair loss, and increased risk of infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through completion of treatment for all enrolled patients (estimated to be 39 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through completion of treatment for all enrolled patients (estimated to be 39 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number and type of adverse events experienced by participants
Secondary outcome measures
Change in HbA1c
Blood Glucose
Body Weight Changes
+5 more

Side effects data

From 2018 Phase 4 trial • 30 Patients • NCT03006471
20%
Cervicovaginal infection
13%
Urinary tract infections
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dapagliflozin
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Group I: Dapagliflozin + Standard of Care carmustine chemotherapy (Ages 6-10)Experimental Treatment2 Interventions
Dapagliflozin will be initiated by mouth once daily at the same time as standard of care carmustine chemotherapy. Dapagliflozin 5 mg by mouth once daily on days 1-84 (duration of study) All patients will stop taking dapagliflozin after 12 weeks of treatment, corresponding to 2 cycles of carmustine. Carmustine chemotherapy dose adjustments will be made per oncologist's judgement.
Group II: Dapagliflozin + Standard of Care carmustine chemotherapy (Ages 11-21)Experimental Treatment2 Interventions
Dapagliflozin will be initiated by mouth once daily at the same time as standard of care carmustine chemotherapy. Dapagliflozin will be initiated at 5 mg by mouth once caily, days 1-4 (2 weeks) Dapagliflozin will be escalated to 10 mg by mouth once daily for the remaining 10 weeks Dose adjustment will need to be approved by endocrinologist Dr. Sprague/or another attending MD diabetologist at SLCH/WUSM on the HRPO-approved study team. This dose is reflective of current clinical practice for diabetes and heart failure. All patients will stop taking dapagliflozin after 12 weeks of treatment, corresponding to 2 cycles of carmustine. Carmustine chemotherapy dose adjustments will be made per oncologist's judgment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dapagliflozin
2014
Completed Phase 4
~64440
Carmustine
1990
Completed Phase 3
~1790

Find a Location

Who is running the clinical trial?

Children's Discovery InstituteUNKNOWN
4 Previous Clinical Trials
455 Total Patients Enrolled
Washington University School of MedicineLead Sponsor
1,935 Previous Clinical Trials
2,299,787 Total Patients Enrolled
Andrew Cluster, M.D.Principal InvestigatorWashington University School of Medicine
2 Previous Clinical Trials
16 Total Patients Enrolled

Media Library

Dapagliflozin Clinical Trial Eligibility Overview. Trial Name: NCT05521984 — Phase 1
Brain Tumor Research Study Groups: Dapagliflozin + Standard of Care carmustine chemotherapy (Ages 11-21), Dapagliflozin + Standard of Care carmustine chemotherapy (Ages 6-10)
Brain Tumor Clinical Trial 2023: Dapagliflozin Highlights & Side Effects. Trial Name: NCT05521984 — Phase 1
Dapagliflozin 2023 Treatment Timeline for Medical Study. Trial Name: NCT05521984 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can those aged sixty and above participate in this experiment?

"This trial stipulates that the minimum age for enrolment is 6 years old, while the maximum acceptable age is 21."

Answered by AI

Are there any available spots for participants in this research endeavor?

"According to the clinicaltrials.gov database, this particular medical study is no longer searching for participants. It was first posted on November 30th 2022 and then last updated a month later on October 25th 2022. Nonetheless, there are 402 other trials that are currently open to enrolment at present time."

Answered by AI

Who qualifies to join this clinical experimentation?

"This clinical study is seeking to recruit twenty individuals aged 6-21 with brain tumours. To be eligible, they must furthermore fulfil the following requirements: chronic primary brain malignancy that cannot be cured; amenable to measurement using RANO criteria; life expectancy of over twelve weeks; prior exposure to radiation, chemotherapy or a combination thereof allowed; blood cell count within set parameters (leukocytes ≥ 3,000/mcL, absolute neutrophil count ≥ 1,500/mcl and platelets ≥ 100,000/mcl); bilirubin ≤ 1.5 x IULN and AST(SGOT"

Answered by AI

Has Dapagliflozin been accepted by the Food and Drug Administration?

"As this is a Phase 1 trial, meaning there hasn't been extensive testing to determine its safety or efficacy, Dapagliflozin was assigned a rating of 1."

Answered by AI
~13 spots leftby Aug 2026