Overview
The purpose of this study is to determine the efficacy of BRain-AVOidant proton craniospinal irradiation (BRAVO pCSI) in adult participants with leptomeningeal metastases from solid tumors.
Eligibility
Inclusion Criteria:
- Participants with leptomeningeal metastases established radiographically and/or through Cerebrospinal Fluid (CSF) cytology or circulating tumor cells (CTCs). Participants may have newly diagnosed or recurrent LM.
- Pathologically confirmed breast or non-small cell lung cancer (NSCLC) primary (group 1 and). Pathologically confirmed solid tumor malignancy (group 2).
- Participants with adequate bone marrow function.
- Participants with a Karnofsky Performance Status (KPS) ≥ 60.
- Male and female participants ages ≥ 18 years.
- Female participants must be of either non-childbearing potential OR must agree to practice an effective contraceptive method.
- Male participants must be of either non-childbearing potential OR must agree to practice an effective contraceptive method.
Exclusion Criteria:
- Participants with metastases within the memory-avoidance structures (hippocampus, corpus callosum, fornix, amygdala) that preclude developing a treatment plan that respects dosimetric constraints for these structures.
- Participants with multiple, serious major neurologic deficits per physician/investigator assessment including encephalopathy.
- Participants with extensive systemic disease and without reasonable systemic treatment options.
- Participants unable to undergo MRI brain and spine with gadolinium contrast.
- Participants who have had radiation therapy to the spinal cord with equivalent dose in 2Gy fractions (EQD2) more than 40Gy or cauda equina with EQD2 more than 50Gy using α/β of 3.
- Female participants who are pregnant or lactating.
- Participants with impaired decision-making capacity.
