Status:
ACTIVE_NOT_RECRUITING
Radiosurgery Before Surgery for the Treatment of Brain Metastases
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Metastatic Malignant Neoplasm in the Brain
Metastatic Malignant Solid Neoplasm
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
This early phase I trial identifies the side effects of stereotactic radiosurgery before surgery in treating patients with cancer that has spread to the brain (brain metastases). Radiation may stimula...
Detailed Description
PRIMARY OBJECTIVE: I. To determine the safety of pre-operative stereotactic radiosurgery (SRS) followed by surgery for brain metastasis. SECONDARY OBJECTIVES: I. To evaluate the immune niche in bra...
Eligibility Criteria
Inclusion
- Age \>= 18 years
- Prior or suspected diagnosis of malignancy
- Brain metastases visible on contrasted magnetic resonance imaging (MRI) brain
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)
- Life expectancy \> 12 weeks as determined by the investigator
- Patients must have adequate organ function as determined by Neurosurgery to undergo surgery
- Willingness and ability of the subject to comply with scheduled visits, study procedures, and study restrictions
- Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation
- Patient must have a negative pregnancy test, be actively taking oral contraceptives or have undergone a hysterectomy
Exclusion
- Patients on any immunosuppressive medication other than dexamethasone
- Patients who are receiving any other investigational agents or an investigational device within 21 days before administration of first dose of study drugs
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Human immunodeficiency virus (HIV)-positive
- Pregnant or nursing women are excluded
- Prior whole brain radiotherapy or SRS to the same site planned for surgery
Key Trial Info
Start Date :
July 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 19 2027
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04895592
Start Date
July 20 2021
End Date
February 19 2027
Last Update
March 21 2025
Active Locations (1)
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1
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322