Trial Outcomes & Findings for Glyburide vs Placebo as Prophylaxis Against Cerebral Edema in Patients Receiving Radiosurgery for Brain Metastases (RAD 1502/UAB 1593) (NCT NCT02460874)
NCT ID: NCT02460874
Last Updated: 2022-09-21
Results Overview
Assessed between the time of glyburide initiation and the time of the one month follow-up MRI.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
1 participants
Primary outcome timeframe
4 months
Results posted on
2022-09-21
Participant Flow
Participant milestones
| Measure |
Pilot Portion
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.
Glyburide: 1.25mg, twice a day
|
Randomized Portion
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.
Glyburide: 1.25mg, twice a day
Placebo: 1.25mg, twice a day
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Glyburide vs Placebo as Prophylaxis Against Cerebral Edema in Patients Receiving Radiosurgery for Brain Metastases (RAD 1502/UAB 1593)
Baseline characteristics by cohort
| Measure |
Pilot Portion
n=1 Participants
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.
Glyburide: 1.25mg, twice a day
|
Randomized Portion
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.
Glyburide: 1.25mg, twice a day
Placebo: 1.25mg, twice a day
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
41 years
STANDARD_DEVIATION 0 • n=5 Participants
|
—
|
41 years
STANDARD_DEVIATION 0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
—
|
0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: Patients
Assessed between the time of glyburide initiation and the time of the one month follow-up MRI.
Outcome measures
| Measure |
Pilot Portion
n=1 Participants
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.
Glyburide: 1.25mg, twice a day
|
Randomized Portion
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.
Glyburide: 1.25mg, twice a day
Placebo: 1.25mg, twice a day
|
|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: Patients
Assessed between the time of SRS and the time of the one month follow-up MRI.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 monthsPopulation: Patients
Measured between the time of SRS and the time of the one and three month post SRS MRI scans.
Outcome measures
| Measure |
Pilot Portion
n=1 Participants
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.
Glyburide: 1.25mg, twice a day
|
Randomized Portion
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.
Glyburide: 1.25mg, twice a day
Placebo: 1.25mg, twice a day
|
|---|---|---|
|
Number of Participants Administered Dexamethasone (or Any Corticosteroid Administration With the Purpose of Treating Cerebral Edema)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: Patients
Incidence of CTCAE version 4.0 reportable toxicities of grades 2-5.
Outcome measures
| Measure |
Pilot Portion
n=1 Participants
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.
Glyburide: 1.25mg, twice a day
|
Randomized Portion
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.
Glyburide: 1.25mg, twice a day
Placebo: 1.25mg, twice a day
|
|---|---|---|
|
Number of Participants With CTCAE Version 4.0 Reportable Toxicities of Grades 2-5.
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 4 monthsPopulation: no patients were accrued to the randomized portion
Incidence of CTCAE version 4.0 reportable toxicities of grades 1-2 Cardiac Disorders or Hepatobiliary Disorders.
Outcome measures
| Measure |
Pilot Portion
n=1 Participants
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.
Glyburide: 1.25mg, twice a day
|
Randomized Portion
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.
Glyburide: 1.25mg, twice a day
Placebo: 1.25mg, twice a day
|
|---|---|---|
|
Number of Participants With CTCAE Version 4.0 Reportable Toxicities of Grades 1-2 Cardiac Disorders or Hepatobiliary Disorders.
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: no patients accrued to the randomized portion
Defined from MRI taken at the time of SRS and the time of the one and three month post SRS MRI scans.
Outcome measures
| Measure |
Pilot Portion
n=1 Participants
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.
Glyburide: 1.25mg, twice a day
|
Randomized Portion
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.
Glyburide: 1.25mg, twice a day
Placebo: 1.25mg, twice a day
|
|---|---|---|
|
Number of Participants With Cerebral Edema Increase as Measured on FLAIR Volumetric Imaging
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: no patients accrued to the randomized portion
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.
Outcome measures
| Measure |
Pilot Portion
n=1 Participants
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.
Glyburide: 1.25mg, twice a day
|
Randomized Portion
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.
Glyburide: 1.25mg, twice a day
Placebo: 1.25mg, twice a day
|
|---|---|---|
|
Number of Participants With Absolute Volume Change of Index Tumor(s)
|
0 Participants
|
0 Participants
|
Adverse Events
Pilot Portion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Randomized Portion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place