Study of Proton Radiation to the Brain and Spinal Cord for Patients With Leptomeningeal Metastases

Completed · Phase 1

Conditions studied: Leptomeningeal Metastases

In brief

The purpose of this study is to find the safest and most effective dose for delivering proton beam to the space containing CSF, brain, and spinal cord, in treating leptomeningeal metastases. The researchers think that using proton beam radiation to treat the space containing CSF, brain, and spinal cord, instead of treating only the areas where the metastasized tumor cells are causing symptoms, would improve the treatment of this disease.

Key facts

Study ID

NCT03520504

Run by

Memorial Sloan Kettering Cancer Center

People needed

24

Starts

2018-04-26

Expected to finish

2022-12-22

Last updated by the study team

2022-12-23

Who can join

Age: 10 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Female subjects must either be of non-reproductive potential (i.e. post-menopausal by history: >/= 60 years old and no menses for 1> year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test within 2 weeks prior to starting treatment.
• Patient with solid tumor malignancy with leptomeningeal metastases established radiographically and/or through CSF cytology.
• KPS ≥ 60.
• Age ≥ 10 years.
• For adult patient, the patient is able to provide informed consent. For pediatric patient, a parent is able to provide informed consent.
• Patient at reproductive potential must agree to practice an effective contraceptive method.
• Adequate bone marrow function:
• Hemoglobin ≥ 8g/dL
• Absolute neutrophil count ≥500/mm\^3
• Platelet count ≥ 100,000/mm\^3

You may not qualify if…

• Patient with multiple, serious major neurologic deficits including encephalopathy.
• Patient with extensive systemic disease and without reasonable systemic treatment options.
• Patient who is unable to undergo MRI brain and spine with gadolinium contrast.
• Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances.
• Pregnant or lactating women.

Where it is running

• Memorial Sloan Kettering Basking Ridge — Basking Ridge, New Jersey, United States
• Memorial Sloan Kettering Monmouth — Middletown, New Jersey, United States
• Memorial Sloan Kettering Bergen — Montvale, New Jersey, United States
• Memorial Sloan Kettering Commack — Commack, New York, United States
• Memorial Sloan Kettering Westchester — Harrison, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Memorial Sloan Kettering Rockville Centre — Rockville Centre, New York, United States
• Memorial Sloan Kettering Nassau — Uniondale, New York, United States

Full record on ClinicalTrials.gov

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