BRain-AVOidant Proton Craniospinal Irradiation for Leptomeningeal Metastases From Solid Tumor Malignancies
A Phase II Study Assessing the Efficacy of BRain-AVOidant Proton Craniospinal Irradiation (CSI) for Leptomeningeal Metastases (LM) From Solid Tumor Malignancies (BRAVO-LM)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how well BRAVO pCSI, a proton radiation treatment designed to avoid parts of the brain, works. It is for adults with cancer from solid tumors that has spread to the tissue and fluid around the brain and spinal cord.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 18 or older.
- Cancer spread to the tissue and fluid around the brain and spinal cord, confirmed by scans or tests of that fluid. The spread may be newly found or have come back.
- Breast cancer, non-small cell lung cancer, or another solid tumor confirmed by a tissue test. The study group depends on the cancer type.
- Bone marrow that makes enough blood cells.
- A score of at least 60 on a daily activity scale, meaning you can meet most personal care needs but may need some help.
- If you can have or father a child, you must agree to use effective birth control.
Who can't join
- Cancer in certain brain areas involved in memory that prevents a radiation plan from meeting dose limits for those areas.
- Several serious problems with brain or nerve function, as judged by the study doctor. These include encephalopathy, a condition that affects how the brain works.
- Widespread cancer in the body with no reasonable treatment options that work throughout the body.
- Unable to have MRI scans of the brain and spine with gadolinium, a dye that helps show details.
- Past radiation above the study's dose limits for the spinal cord or the nerve bundle at the bottom of the spine.
- Pregnant or breastfeeding.
- Unable to make informed decisions.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. 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. 2. Pathologically confirmed breast or non-small cell lung cancer (NSCLC) primary (group 1 and). Pathologically confirmed solid tumor malignancy (group 2). 3. Participants with adequate bone marrow function. 4. Participants with a Karnofsky Performance Status (KPS) ≥ 60. 5. Male and female participants ages ≥ 18 years. 6. Female participants must be of either non-childbearing potential OR must agree to practice an effective contraceptive method. 7. Male participants must be of either non-childbearing potential OR must agree to practice an effective contraceptive method. Exclusion Criteria: 1. 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. 2. Participants with multiple, serious major neurologic deficits per physician/investigator assessment including encephalopathy. 3. Participants with extensive systemic disease and without reasonable systemic treatment options. 4. Participants unable to undergo MRI brain and spine with gadolinium contrast. 5. 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. 6. Female participants who are pregnant or lactating. 7. Participants with impaired decision-making capacity.
Study sites (1)
FL
- University of Miami · Miami, FL 33136Morgan Freret, MD · Study contact · (305) 243-5470 · mfreret@miami.eduMarkus Bredel, MD · Study contact · (305) 243-4263 · mbredel@miami.eduMorgan Freret, MD · Principal investigatorMore trials in Miami