A Phase 1/2 interventional study of Glyburide and Placebo in Cerebral Edema and Brain Metastases, sponsored by University of Alabama at Birmingham. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-21.
Sponsored by University of Alabama at Birmingham · Phase 1/2, Interventional, and Treatment
Primary Objectives:
Pilot Portion: To determine the feasibility and safety of administering oral glyburide to non-diabetic patients receiving stereotactic radiosurgery (SRS) for newly diagnosed brain metastases.
Randomized Portion: To determine the number of patients with newly diagnosed brain metastases who have an increase in edema as measured on volumetric FLAIR imaging and the number of patients that require dexamethasone administration (or any corticosteroid administration with the purpose of treating cerebral edema) from the day of SRS to one month follow-up MRI in the group receiving glyburide versus placebo.
Many patients with cancer that has spread to the brain have side effects caused by swelling around the tumors. A common treatment for this swelling is a medicine called dexamethasone. Dexamethasone is a steroid. Long-term use of steroids has several known side effects.
Recent studies have shown that a drug commonly used in to control high blood sugar in diabetes, called glyburide, can decrease brain swelling in patients with brain damage or stroke. Animal studies have shown that this drug may also reduce swelling from tumors in the brain. Researchers are interested in whether glyburide could treat brain swelling as well as dexamethasone with fewer side effects.
This study is being done to see whether glyburide is safe to be used in patients without diabetes in combination with receiving SRS for brain metastases. This study will also find out if glyburide will decrease brain swelling in patients that get radiosurgery (SRS) for brain metastases. This study will also find out if taking glyburide will decrease the chance of needing steroids due to brain swelling that is causing symptoms. It is not yet known, but it is the investigators' hope that glyburide will both decrease brain swelling and lessen the chance of needing steroids.
CBC with differential and CMP including Liver Function Tests (LFTs) obtained within 14 days prior to registration and meeting the following requirements:
For the Randomized Portion only: Subject must have at least 2 of the following risk factors: {For the Pilot Portion, it is not required that patients have the risk factors mentioned in Inclusion Criteria 9.}
Exclusion Criteria:
Step 1: Patients with brain metastases requiring SRS and not taking corticosteroids 5 days prior to SRS. Treatment planning MRI may be done within 21 days prior to SRS treatment. Step 2: Take Glyburide 1.25mg (twice a day by mouth) beginning 5 days prior to SRS. Receive glucose monitoring materials and blood glucose education- begin glucose monitoring (4 times a day). Step 3: 1 week after SRS, return to clinic to review glucose logs- continue glyburide and blood glucose monitoring. Step 4: 1 month after SRS, discontinue both glyburide and blood glucose monitoring, undergo MRI. Step 5: 3 months after SRS, undergo MRI.
Drug: Glyburide
Step 1: Patients with brain metastases requiring SRS and not taking corticosteroids 5 days prior to SRS.Treatment planning MRI may be done within 21 days prior to SRS treatment. Step 2: Randomization (1:1) * Group 1: take Glyburide (1.25mg, twice a day by mouth) beginning 5 days prior to SRS. Receive glucose monitoring materials and blood glucose education. Begin glucose monitoring (once a day) {This portion will be double blinded}. * Group 2: Take Placebo (1 pill, twice a day by mouth) beginning 5 days prior to SRS. Receive glucose monitoring materials and blood glucose education. Begin glucose monitoring (once a day) {This portion will be double blinded}. Step 3: 1 week after SRS, return to clinic to review glucose logs, continue investigation medication, but discontinue glucose monitoring. Step 4: 1 month after SRS, discontinue investigation medication, undergo MRI. Step 5: 3 months after SRS, undergo MRI.
Drug: Glyburide · Other: Placebo
1.25mg, twice a day
1.25mg, twice a day
Number of Participants With Dose Limiting Toxicities (DLTs)
Assessed between the time of glyburide initiation and the time of the one month follow-up MRI.
Time frame: 4 months
Randomized Portion: Occurrence of Edema Increase and Initiation of Dexamethasone (or Any Corticosteroid Administration With the Purpose of Treating Cerebral Edema)
Assessed between the time of SRS and the time of the one month follow-up MRI.
Time frame: 4 months
Number of Participants Administered Dexamethasone (or Any Corticosteroid Administration With the Purpose of Treating Cerebral Edema)
Measured between the time of SRS and the time of the one and three month post SRS MRI scans.
Time frame: 4 months
Number of Participants With CTCAE Version 4.0 Reportable Toxicities of Grades 2-5.
Incidence of CTCAE version 4.0 reportable toxicities of grades 2-5.
Time frame: 4 months
Number of Participants With CTCAE Version 4.0 Reportable Toxicities of Grades 1-2 Cardiac Disorders or Hepatobiliary Disorders.
Incidence of CTCAE version 4.0 reportable toxicities of grades 1-2 Cardiac Disorders or Hepatobiliary Disorders.
Time frame: Up to 4 months
Number of Participants With Cerebral Edema Increase as Measured on FLAIR Volumetric Imaging
Defined from MRI taken at the time of SRS and the time of the one and three month post SRS MRI scans.
Time frame: 4 months
Number of Participants With Absolute Volume Change of Index Tumor(s)
Absolute volume change of index tumor(s) that received radiosurgery as manually contoured by the radiation oncologist defined from T1 post gadolinium sequences at the time of SRS and the time of the one and three month post SRS MRI scans.
Time frame: 4 months
| Milestone | Pilot Portion | Randomized Portion |
|---|---|---|
| Started | 1 | 0 |
| Completed | 1 | 0 |
| Not completed | 0 | 0 |
Assessed between the time of glyburide initiation and the time of the one month follow-up MRI.
| Participants | Pilot Portion | Randomized Portion |
|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLTs) | 0 | 0 |
Assessed between the time of SRS and the time of the one month follow-up MRI.
No measurements were reported for this outcome.
Measured between the time of SRS and the time of the one and three month post SRS MRI scans.
| Participants | Pilot Portion | Randomized Portion |
|---|---|---|
| Number of Participants Administered Dexamethasone (or Any Corticosteroid Administration With the Purpose of Treating Cerebral Edema) | 0 | 0 |
Incidence of CTCAE version 4.0 reportable toxicities of grades 2-5.
| Participants | Pilot Portion | Randomized Portion |
|---|---|---|
| Number of Participants With CTCAE Version 4.0 Reportable Toxicities of Grades 2-5. | 0 | 0 |
Incidence of CTCAE version 4.0 reportable toxicities of grades 1-2 Cardiac Disorders or Hepatobiliary Disorders.
| Participants | Pilot Portion | Randomized Portion |
|---|---|---|
| Number of Participants With CTCAE Version 4.0 Reportable Toxicities of Grades 1-2 Cardiac Disorders or Hepatobiliary Disorders. | 0 | 0 |
Defined from MRI taken at the time of SRS and the time of the one and three month post SRS MRI scans.
| Participants | Pilot Portion | Randomized Portion |
|---|---|---|
| Number of Participants With Cerebral Edema Increase as Measured on FLAIR Volumetric Imaging | 1 | 0 |
Absolute volume change of index tumor(s) that received radiosurgery as manually contoured by the radiation oncologist defined from T1 post gadolinium sequences at the time of SRS and the time of the one and three month post SRS MRI scans.
| Participants | Pilot Portion | Randomized Portion |
|---|---|---|
| Number of Participants With Absolute Volume Change of Index Tumor(s) | 0 | 0 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pilot Portion | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Randomized Portion | — | — | — |
terminated early
| Age, Categorical(Participants) | Pilot Portion | Randomized Portion | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 0 | 1 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Pilot Portion | Randomized Portion | Total |
|---|---|---|---|
| Mean | 41 ± 0 | — | 41 ± 0 |
| Sex: Female, Male(Participants) | Pilot Portion | Randomized Portion | Total |
|---|---|---|---|
| Female | 1 | 0 | 1 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Pilot Portion | Randomized Portion | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 1 | 0 | 1 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Pilot Portion | Randomized Portion | Total |
|---|---|---|---|
| United States | 1 | — | 0 |
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University of Alabama at Birmingham