Status:
TERMINATED
Radiosurgery Dose Reduction for Brain Metastases on Immunotherapy (RADREMI): A Prospective Pilot Study
Lead Sponsor:
Indiana University
Conditions:
Brain Tumor
Brain Metastases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study will evaluate the rate of radiation necrosis following treatment with immune checkpoint inhibitor (ICI) treatment and radiation therapy in subjects with metastatic brain cancer. Subjects wi...
Detailed Description
This is a prospective, single arm, pilot study to determine the symptomatic radiation necrosis rate at 6 months utilizing dose-reduced stereotactic radiosurgery with immunotherapy for subjects with a ...
Eligibility Criteria
Inclusion
- Brain MRI-confirmed 1-10 solid tumor brain metastases
- Biopsy-confirmed primary malignancy
- ds-GPA estimated median survival of at least 6 months, for histologies not included in the ds-GPA, publications or noted online at brainmetgpa.com, the PI will use either published or validated data or their best clinical judgment to determine the patient's expected survival
- Stereotactic radiosurgery candidate per treating Radiation Oncologist
- ≥ 18 years old at the time of informed consent
- Ability to provide written informed consent and HIPAA (Health Insurance Portability and Accountability Act) authorization.
- ALC \> 800/ul (Ku et al., 2010)
- Patients currently on cytotoxic chemotherapy are eligible
- Patients receiving ICI up to 30 days prior to delivery of SRS are eligible
- Patients having undergone operative resection for metastatic brain disease within 30 days of immune checkpoint inhibitor (ICI) administration are eligible.
Exclusion
- Major medical illnesses or psychiatric impairments, which in the investigator's opinion will prevent administration or completion of the protocol therapy and/or interfere with follow-up
- Patients unable to receive MRI Brain
- Patients with more than 10 brain metastases on MRI Brain imaging
- Any lesion \> 4 centimeter maximum diameter
- Total volume of metastatic disease more than 30 cubic centimeters
- Previous whole brain radiation therapy
- For Cohort 1: Previous stereotactic radiosurgery where the 50% isodose line overlaps with current treatment field
- For Cohort 2: Patients whose treatment will have a dose overlap within the target from prior treatments of 20% or greater
- Already receiving chronic dexamethasone (chronic = \> 2 weeks) prior to SRS
- Not a radiosurgical candidate per Radiation Oncology discretion
- Existing autoimmune disease
- Patients who have an unknown primary cancer
- Histology not amenable for SRS (i.e. lymphoma). (Small Cell Lung Cancer IS amenable.)
Key Trial Info
Start Date :
December 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 20 2024
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04047602
Start Date
December 12 2019
End Date
February 20 2024
Last Update
February 13 2025
Active Locations (3)
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1
Indiana University Health Hospital
Indianapolis, Indiana, United States, 46202
2
Indiana University Methodist Hospital
Indianapolis, Indiana, United States, 46202
3
Oregon Health and Sciences
Portland, Oregon, United States, 97239