Dapagliflozin + Standard of Care BCNU (carmustine) chemotherapy for Pediatric Brain Tumors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Washington University School of Medicine, Saint Louis, MO
Pediatric Brain Tumors+1 More
Carmustine - Drug
Eligibility
< 65
All Sexes
What conditions do you have?
Select

Study Summary

This is a pilot study of the feasibility and safety of dapagliflozin (in addition to standard of care treatment) for the treatment of pediatric patients with recurrent brain 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.

Eligible Conditions

  • Pediatric Brain Tumors

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Pediatric Brain Tumors

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: Through completion of treatment for all enrolled patients (estimated to be 39 months)

Month 3
Change in HbA1c
Change in blood glucose
Change in ketones
Changes in c-peptide
Changes in fructosamine
Changes in glucagon
Week 12
Tumor response rate
Month 4
Number and type of adverse events experienced by participants
Month 39
Feasibility of regimen

Trial Safety

Safety Progress

1 of 3

Other trials for Pediatric Brain Tumors

Trial Design

1 Treatment Group

Dapagliflozin + Standard of Care BCNU (carmustine) chemotherapy
1 of 1
Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: Dapagliflozin + Standard of Care BCNU (carmustine) chemotherapy · No Placebo Group · Phase 1

Dapagliflozin + Standard of Care BCNU (carmustine) chemotherapyExperimental Group · 2 Interventions: Carmustine, Dapagliflozin · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carmustine
1990
Completed Phase 3
~1850
Dapagliflozin
2017
Completed Phase 4
~39870

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through completion of treatment for all enrolled patients (estimated to be 39 months)
Closest Location: Washington University School of Medicine · Saint Louis, MO
Photo of washington university school of medicine  1Photo of washington university school of medicine  2Photo of washington university school of medicine  3
2004First Recorded Clinical Trial
2 TrialsResearching Pediatric Brain Tumors
1465 CompletedClinical Trials

Eligibility Criteria

Age < 65 · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a primary brain tumor with no curative therapy available.
You have a life expectancy of at least 12 weeks.
You have a total bilirubin of ≤ 1.5 times the upper limit of normal.
AST/ALT ratio of AST/ALT > 3.0 x IULN.
Measurable disease using pediatric Response Assessment in Neuro-Oncology Criteria (RANO) criteria.
Prior treatment with radiation alone, chemotherapy alone or combined radiation and chemotherapy is allowed.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.