Study of Craniospinal Irradiation With Linac Based Volumetric Modulated Arc Therapy (VMAT) for Patients With Leptomeningeal Metastasis

Launched by NYU LANGONE HEALTH · May 14, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new method of radiation therapy called Volumetric Modulated Arc Therapy (VMAT) to treat patients with leptomeningeal metastasis, which is when cancer spreads to the membranes surrounding the brain and spinal cord. The goal is to see if this new approach can help improve the time patients live without their cancer worsening in the central nervous system compared to older radiation techniques.

To be eligible for this trial, participants must be at least 18 years old and have solid tumor cancers that have spread to the membranes around the brain and spine. They should also be able to safely receive radiation therapy and have some treatment options available for their cancer. If you join this study, you will receive VMAT treatment and will be monitored closely for your health and response to the therapy. It’s important to know that this trial is not yet recruiting participants, so it may take some time before it starts.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Solid tumor cancer primary with leptomeningeal metastases established radiographically and/or by CSF cytology
• • 2. Candidate for radiation therapy for the treatment of leptomeningeal metastases
• • 3. If patient had prior radiation, a treatment plan can be generated that will not exceed normal tissue tolerances
• • 4. Patient must have reasonable systemic treatment options, as confirmed by their medical oncologist
• • 5. Age ≥ 18 years old
• • 6. Able to provide informed consent
• • 7. Karnofsky Performance Scale (KPS) ≥ 60
• • 8. Adequate hematologic baseline
• • 1. Hemoglobin \> 8g/dL
• • 2. Absolute neutrophil count \>1,000/mm3
• • 3. Platelet count \> 100,000/mm3
• • 9. Female subjects must either be of
• • 1. Non-reproductive potential (over 60 years old, or without menses for at least 1 year without an alternative medical cause)
• • 2. Have history of hysterectomy, bilateral tubal ligation, or bilateral oophorectomy
• • 3. Must have negative serum/urine pregnancy test
• • 4. If of reproductive age, must practice effective contraceptive method
• Exclusion Criteria:
• • 1. Patient has multiple severe neurologic deficits per physician assessment
• • 2. Patient has diffuse systemic disease without reasonable systemic therapy options
• • 3. Patient is unable to undergo MRI brain and spine with gadolinium contrast
• • 4. Prior radiation that would preclude development of a treatment plan that respects normal tissue constraints
• • 5. Pregnant or lactating women
• • 6. Prisoners