Glyburide vs Placebo as Prophylaxis Against Cerebral Edema in Patients

Status Terminated

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02460874
Study type	Interventional
Source	University of Alabama at Birmingham
Contact
Status	Terminated
Phase	Phase 1/Phase 2
Start date	August 16, 2017
Completion date	May 19, 2021

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04074096` - Binimetinib Encorafenib Pembrolizumab +/- Stereotactic Radiosurgery in BRAFV600 Melanoma With Brain Metastasis	Phase 2
Recruiting	`NCT04474925` - Pre- Versus Post-operative SRS for Resectable Brain Metastases	Phase 3
Recruiting	`NCT05358340` - Dual Perfusion Imaging for Characterizing Vascular Architecture of Brain Lesions	N/A
Recruiting	`NCT05559853` - Developing a New MRI Technique to Understand Changes in Brain Tumors After Treatment
Completed	`NCT03189381` - Pilot Phase 2 Study Whole Brain Radiation Therapy With Simultaneous Integrated Boost for Patients With Brain Metastases	N/A
Completed	`NCT02082587` - Toronto BNB Pilot Study	N/A
Terminated	`NCT01551680` - A Trial Evaluating Concurrent Whole Brain Radiotherapy and Iniparib in Multiple Non Operable Brain Metastases	Phase 1
Terminated	`NCT00717275` - Study of Temozolomide to Treat Newly Diagnosed Brain Metastases	Phase 2
Recruiting	`NCT05048212` - A Phase II Study of Nivolumab With Ipilimumab and Cabozantinib in Patients With Untreated Renal Cell Carcinoma Brain Metastases	Phase 2
Recruiting	`NCT03714243` - Blood Brain Barrier Disruption (BBBD) Using MRgFUS in the Treatment of Her2-positive Breast Cancer Brain Metastases	N/A
Recruiting	`NCT05573815` - Evaluation of Clinical Decision Support System for Brain Metastasis Using Brain MR Images	N/A
Recruiting	`NCT04899908` - Stereotactic Brain-directed Radiation With or Without Aguix Gadolinium-Based Nanoparticles in Brain Metastases	Phase 2
Completed	`NCT04507217` - Tislelizumab Combined With Pemetrexed/ Carboplatin in Patients With Brain Metastases of Non-squamous NSCLC	Phase 2
Recruiting	`NCT05452005` - Fluorine-18-AlphaVBeta6-Binding Peptide Positron Emission Tomography in Metastatic Non-Small Cell Lung Cancer	Phase 1
Completed	`NCT04170777` - Perfexion Registration Using CBCT
Recruiting	`NCT03027544` - Tomotherapy for Refractory Brain Metastases	N/A
Completed	`NCT04178330` - Tomotherapy as Primary Radiotherapy for Multipule Brain Metastases	N/A
Terminated	`NCT02187822` - Fractionated Stereotactic Radiotherapy (FSRT) in Treatment of Brain Metastases	Phase 1
Terminated	`NCT00538343` - RTA 744 in Breast Cancer Patients With Progression of Previously Irradiated Brain Metastases	Phase 2
Completed	`NCT03653546` - First Line Treatment in EGFR Mutation Positive Advanced NSCLC Patients With Central Nervous System (CNS) Metastases	Phase 2/Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Glyburide vs Placebo as Prophylaxis Against Cerebral Edema in Patients Receiving Radiosurgery for Brain Metastases (RAD 1502/UAB 1593)

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms