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

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT05521984
Phase
PHASE1
Status
Recruiting
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Conditions

  • Pediatric Brain Tumor
  • Pediatric Solid Tumor

Eligibility Criteria

Sex
ALL
Age
6 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    Commercially available
  • Carmustine — DRUG
    Standard of care
  • Topotecan — DRUG
    Standard of care
  • Cyclophosphamide — DRUG
    Standard of care

Study Details

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.

Key Dates

Start date
Apr 3, 2023
Status verified
Jun 2026
Primary completion
Mar 31, 2031
Completion
Jun 30, 2031

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Brain Cancer: Dapagliflozin + Standard of Care Chemotherapy (Ages 6-10)
    * Dapagliflozin will be initiated by mouth once daily at the same time as standard of care chemotherapy (carmustine). * 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.
  • Experimental: Brain Cancer: Dapagliflozin + Standard of Care Chemotherapy (Ages 11-29)
    * Dapagliflozin will be initiated by mouth once daily at the same time as standard of care chemotherapy (carmustine). * Dapagliflozin will be initiated at 5 mg by mouth once daily, days 1-4 (2 weeks) * Dapagliflozin will be escalated to 10 mg by mouth once daily for the remaining 10 weeks (after consultation with study endocrinologist) * All patients will stop taking dapagliflozin after 12 weeks of treatment.
  • Experimental: Solid Tumor Cancer: Dapagliflozin + Standard of Care Chemotherapy (Ages 6-10)
    * Dapagliflozin will be initiated by mouth once daily at the same time as standard of care chemotherapy (topotecan + cyclophosphamide). * 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. * Each cycle is 21 days.
  • Experimental: Solid Tumor Cancer: Dapagliflozin + Standard of Care Chemotherapy (Ages 11-29)
    * Dapagliflozin will be initiated by mouth once daily at the same time as standard of care chemotherapy (topotecan + cyclophosphamide). * Dapagliflozin will be initiated at 5 mg by mouth once daily, days 1-4 (2 weeks) * Dapagliflozin will be escalated to 10 mg by mouth once daily for the remaining 10 weeks (after consultation with study endocrinologist) * All patients will stop taking dapagliflozin after 12 weeks of treatment. * Each cycle is 21 days.

Primary Outcome Measure

Number and type of adverse events experienced by participants [ Time Frame: From start of treatment through 30 days after last day of dapagliflozin treatment (estimated to be 4 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of Medicine/St. Louis Children's HospitalSt LouisMissouri63110
Andrew Cluster, M.D.
[email protected]
314-273-1451
Andrew Cluster, M.D. (PRINCIPAL_INVESTIGATOR)
Joseph Ippolito, M.D., Ph.D. (SUB_INVESTIGATOR)
Jennifer Sprague, M.D., Ph.D. (SUB_INVESTIGATOR)
Linda Peterson, M.D. (SUB_INVESTIGATOR)
Amy Armstrong, M.D. (SUB_INVESTIGATOR)
Jingqin (Rosy) Luo, Ph.D. (SUB_INVESTIGATOR)

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By research site
Washington University School of Medicine/St. Louis Children's Hospital· St Louis, MO

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