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

Study Purpose

The purpose of this study is to confirm the safety and efficacy of linac based Volumetric Modulated Arc Therapy (VMAT) for craniospinal irradiation (CSI) in solid tumor cancer patients with leptomeningeal metastasis. The primary aim is to determine if linac based VMAT CSI for leptomeningeal metastasis improves central nervous system (CNS) progression free survival (PFS) compared to the historical standard control CNS PFS in patients treated with Involved Field Radiation Therapy (IFRT).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06984523
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	NYU Langone Health
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Benjamin Cooper, MD
Principal Investigator Affiliation	NYU Langone Health
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Leptomeningeal Metastasis

Arms & Interventions

Arms

Experimental: Linac based Volumetric Arc Therapy (VMAT) CSI

Radiation dose will be administered according to the physician's written directive. Treatment will be administered once a day, Monday through Friday, for a total of ten fractions.

Interventions

Radiation: - Varian Eclipse

Varian TrueBeam linear accelerator with photon beam Volumetric Modulated Arc Therapy (VMAT) capability. Subjects will receive 3000 centigray (cGy) in 10 fractions at 300 cGy per fraction.

Contact a Trial Team

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NYU Langone Health, New York, New York

Status

Address

NYU Langone Health

New York, New York, 10016

Site Contact

[email protected]

212-731-5003

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