What side effects are associated with this type of intervention?

SGLT2 inhibitors, such as dapagliflozin, are primarily used to manage blood glucose levels by preventing glucose reabsorption in the kidneys. Common side effects include urinary tract infections, genital infections, and an increased risk of diabetic ketoacidosis. In the context of brain tumor treatments, side effects can vary widely depending on the specific therapy but often include fatigue, nausea, vomiting, and increased susceptibility to infections. Chemotherapy and radiation, common treatments for brain tumors, can also lead to hair loss, cognitive changes, and hematologic issues such as anemia and thrombocytopenia.

What prior FDA approvals exist?

Currently, there are no FDA-approved treatments for brain tumors that are similar to dapagliflozin, an SGLT2 inhibitor. However, various other treatments have been approved for brain tumors, including chemotherapeutic agents like temozolomide and targeted therapies such as bevacizumab. These treatments focus on different mechanisms, such as DNA damage and inhibition of angiogenesis, respectively, rather than glucose reabsorption inhibition.

What other types of research exist?

Promising novel alternatives to dapagliflozin for brain tumor patients include FGFR inhibitors like infigratinib and futibatinib, which target FGFR2 gene fusions or rearrangements in cholangiocarcinoma and have shown efficacy in clinical trials. These therapies are being explored for their potential in treating various cancers, including brain tumors.

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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

No Placebo-Only Group

Summary

This trial is testing whether dapagliflozin, a drug that helps lower blood sugar, is safe for brain tumor patients who are receiving chemotherapy. The goal is to see if the medication can be used without causing significant side effects. Dapagliflozin works by helping the kidneys remove sugar from the blood, which is then passed out in urine.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ through completion of treatment for all enrolled patients (estimated to be 39 months)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number and type of adverse events experienced by participants

Secondary study objectives

Feasibility of regimen

Tumor response rate

Side effects data

From 2018 Phase 4 trial • 30 Patients • NCT03006471

20%

Cervicovaginal infection

13%

Urinary tract infections

100%

80%

60%

40%

20%

Study treatment Arm

Dapagliflozin

Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 (after consultation with study endocrinologist) * All patients will stop taking dapagliflozin after 12 weeks of treatment. * Carmustine chemotherapy dose adjustments will be made per oncologist's judgment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carmustine

1990

Completed Phase 3

~1820

Dapagliflozin

2014

Completed Phase 4

~64440

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

SGLT2 inhibitors, such as dapagliflozin, reduce blood glucose levels by preventing glucose reabsorption in the kidneys, which may be beneficial for brain tumor patients as high glucose levels can fuel tumor growth. Other common treatments for brain tumors include chemotherapy agents like temozolomide, which damages the DNA of cancer cells, and dietary interventions like ketogenic diets that reduce glucose availability to tumor cells. These treatments are crucial as they target the metabolic vulnerabilities of brain tumors, potentially slowing their growth and improving patient outcomes.

Ketogenic Diet for Malignant Gliomas: a Review.Metformin as Potential Therapy for High-Grade Glioma.The impact of hyperglycemia on survival in glioblastoma: A systematic review and meta-analysis.