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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 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)
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 moreSide effects data
From 2018 Phase 4 trial • 30 Patients • NCT0300647120%
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
2,299,790 Total Patients Enrolled
Andrew Cluster, M.D.Principal InvestigatorWashington University School of Medicine
2 Previous Clinical Trials
16 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can understand and am willing to sign the consent form.My HbA1c level is above 8.5%, and I am not using insulin.I am not taking more than 4 mg/day of dexamethasone.I have had radiation, chemotherapy, or both before.My oxygen levels are normal without assistance, or my lung function test is above 80% if not.My kidney function is normal or only slightly above normal.I can care for myself but may need occasional help.I do not have any severe ongoing illnesses or infections.My brain tumor has come back and cannot be cured.I am between 6 and 21 years old.My blood tests for bone marrow and organ function are normal.I had cancer before, but it was treated over 2 years ago and I'm now cancer-free, except for minor skin cancers.I have type 1 diabetes or am currently on insulin.I have HIV but my CD4+ T-cell count is above 350 and I haven't had an AIDS-related infection in the last year.I have had a stroke or a mini-stroke in the past 5 years.I have been treated with SGLT2 inhibitors or thiazolidinediones.I have no allergies to dapagliflozin, carmustine, or similar medications.
Research Study Groups:
This trial has the following groups:- Group 1: Dapagliflozin + Standard of Care carmustine chemotherapy (Ages 11-21)
- Group 2: Dapagliflozin + Standard of Care carmustine chemotherapy (Ages 6-10)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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