Actively Recruiting
A Randomized Trial Evaluating GLIADEL Compared to Stereotactic Radiosurgery in Subjects With Metastatic Brain Disease
Led by University of Nebraska · Updated on 2026-04-28
100
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University of Nebraska
Lead Sponsor
A
Arbor Pharmaceuticals, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether placing GLIADEL wafers, a local chemotherapy, directly into the site where a metastatic brain tumor was surgically removed can prevent the tumor from coming back as well as stereotactic radiosurgery (SRS) given after surgery. This trial is for adults with one to four metastatic brain tumors, focusing on comparing GLIADEL to SRS after tumor removal to see which better prevents local recurrence. Participants with certain types of cancers or prior brain radiation are not eligible, and they should have a life expectancy greater than three months. Participants will be randomly assigned during surgery to either receive GLIADEL wafers placed in the resection cavity immediately after tumor removal or to receive SRS to the cavity within six weeks after surgery. Any other tumors will be treated with SRS. The amount of GLIADEL wafers used depends on the cavity size to cover as much area as possible. Before surgery, participants will have brain MRI scans and cognitive testing. After surgery, another MRI will check how much tumor was removed. Participants will be monitored regularly to check for tumor recurrence and changes in cognitive function. Researchers will also analyze the genetic makeup of the brain tumor compared to the primary cancer and normal cells. The main outcome measured is how effective GLIADEL is compared to SRS over 12 months.
CONDITIONS
Brief Title
A Study Comparing GLIADEL to Stereotactic Radiosurgery in Metastatic Brain Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older (19 years in Nebraska)
- Recursive partitioning analysis (RPA) class I, II or III with Karnofsky Performance Status (KPS) of 60 or higher
- Known or suspected primary solid cancer with up to four metastatic brain tumors, with at least one tumor planned for surgical removal and GLIADEL placement at one site
- Laboratory values adequate for safe surgery as determined by the neurosurgeon
- Negative pregnancy test within 7 days before starting the study for women of childbearing potential
- Normal coagulation studies with INR less than or equal to 1.3
- Estimated survival time of at least 3 months
- Participant willing and able to consent and follow the study protocol
You will not qualify if you...
- Prior treatment to the planned surgical area, including surgery or radiation
- Prior whole brain radiation therapy
- Diagnosis of lymphoma, germ cell cancer, small cell lung cancer, or anaplastic thyroid cancer
- Leptomeningeal disease
- Neurodegenerative disorders such as dementia
- Tumor size greater than 4 cm
- Karnofsky Performance Status (KPS) less than 60
- Inability or unwillingness to follow the study protocol
- Any significant medical, laboratory, or psychiatric condition that may interfere with study participation or safety
- Participation in other therapeutic clinical trials
- Severe heart, lung, or systemic disease including certain heart failure or arrhythmias
- Bleeding disorders or use of anticoagulants/antiplatelet drugs that cannot be stopped for surgery
- Inability to have MRI studies performed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessments
Duration - Up to 6 weeks from surgery
Participants undergo surgical removal of the metastatic brain tumor. Depending on randomization, participants either receive GLIADEL wafer placement in the tumor cavity immediately after surgery or stereotactic radiosurgery (SRS) within 6 weeks post-surgery to the resection cavity and any other lesions.
1 surgical visit and SRS within 6 weeks post-surgery if applicable
Duration - Up to 12 months
Participants are followed at set intervals to monitor for local tumor recurrence and neurocognitive changes after treatment.
Regular follow-up visits at set intervals for evaluations
Trial Site Locations
Total: 2 locations
1
Henry Ford
Detroit, Michigan, United States, 48202
Not Yet Recruiting
2
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
Research Team
P
Project Coordinator
T
Taylor A Johnson, BS, MA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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