Comparing GLIADEL and Stereotactic Radiosurgery for Metastatic Brain Tumors
A Randomized Trial Evaluating GLIADEL Compared to Stereotactic Radiosurgery in Subjects With Metastatic Brain Disease
This study is testing whether a local chemotherapy treatment called GLIADEL can help prevent brain tumors from coming back after surgery, compared to a treatment called stereotactic radiosurgery, for adults with metastatic brain tumors.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Nebraska Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 2 sites (Detroit, Michigan and 1 other locations) |
| Trial ID | NCT04222062 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of GLIADEL, a local chemotherapy treatment, in preventing the recurrence of metastatic brain tumors after surgical resection, compared to stereotactic radiosurgery (SRS). A total of 100 adult participants with one to four metastatic brain tumors will be enrolled, with randomization occurring at the time of surgery to either receive GLIADEL or SRS. Participants will undergo pre-operative evaluations, including MRI and neuropsychological testing, and will be monitored for local recurrence and cognitive changes post-treatment. The study aims to compare the genomic characteristics of the metastatic tumors to their primary tumors.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 years or older with one to four metastatic brain tumors, one of which requires surgical resection.
Not a fit: Patients with prior radiation treatment, certain types of cancer such as lymphoma or small cell cancer, or those with a life expectancy of less than three months may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve local control of metastatic brain tumors and enhance patient outcomes.
How similar studies have performed: Other studies have shown promise in using local chemotherapy and SRS for brain tumors, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Age 18 years or older (in states with 18 as age of majority); Age 19 years or older in Nebraska (age of majority) * Recursive partitioning analysis (RPA) class I, II or III with a Karnofsky Performance Status (KPS) of \>/ 60 * Known or suspected primary solid cancer with metastatic brain tumor(s) - up to four in number and up to 4 cm in size with surgical resection planned for at least one site with Gliadel placement planned for only one site * Laboratory values adequate for patient to undergo surgery safely as determined by the attending neurosurgeon (transfusion permitted to reach goals) * Women of childbearing potential must have a negative pregnancy test within 7 days of initiating study. (No childbearing potential is defined as age 55 years or older and no menses for two years or any age with surgical removal of the uterus and/or both ovaries) * Normal coagulation studies (international normalized ratio, INR, ≤ 1.3) * Estimated survival time of ≥ 3 months (determined by the participant's primary oncologist) * Participant is willing and able to consent and abide by the protocol Exclusion criteria: * Prior treatment to the area of planned resection (surgery, radiation) * Prior whole brain radiation therapy * Diagnosis of lymphoma, germ cell cancer, small cell lung cancer, anaplastic thyroid cancer * Leptomeningeal disease * Neurodegenerative disorder (e.g. dementia) * Tumor size \> 4 cm * Karnofsky Performance Status (KPS) \< 60 * Inability or unwillingness to co-operate with the requirements of the protocol * Any other clinically significant medical disease or condition, laboratory abnormality or psychiatric illness that, in the Investigator's opinion, may interfere with protocol adherence or confound efficacy or safety assessment or a subject's ability to give informed consent * Simultaneous participation in other therapeutic clinical trials * Severe pulmonary, cardiac or other systemic disease, specifically: * New York Heart Association \> Grade 2 congestive heart failure within 6 months prior to study entry, unless asymptomatic and well controlled with medication * Uncontrolled or significant cardiovascular disease, clinically significant ventricular arrhythmia (such as ventricular tachycardia, ventricular fibrillation, or Torsades des pointes), clinically significant pulmonary disease (such as ≥ Grade 2 dyspnea, according to Common Terminology Criteria for Adverse Events 5.0) * Participants having any other disease, either metabolic or psychological, which as per Investigator assessment may affect the participant's compliance or place the participant at higher risk of potential treatment complications * Participant has a bleeding diathesis, or must take anticoagulants, or antiplatelet agents including non-steroidal anti-inflammatory drugs (NSAIDs) at the time of scheduled resection that cannot be stopped for surgery * Inability to obtain MRI studies
Where this trial is running
Detroit, Michigan and 1 other locations
- Henry Ford — Detroit, Michigan, United States (Not_yet_recruiting)
- University of Nebraska Medical Center — Omaha, Nebraska, United States (Recruiting)
Study contacts
- Principal investigator: Michele Aizenberg, MD — University of Nebraska
- Study coordinator: Project Coordinator
- Email: IITOffice@unmc.edu
- Phone: 402-559-0963
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.