Clinical Trial Details
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NCT03520504 : Study of Proton Radiation to the Brain and Spinal Cord for Patients With Leptomeningeal Metastases
PhasePhase 1
AgesMin: 10 Years Max: N/A
Inclusion Criteria:

- 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

- Adequate bone marrow function:

- Hemoglobin = 10g/dL

- Absolute neutrophil count =1,500/mm^3

- Platelet count = 100,000/mm^3

Exclusion Criteria:

- Patient with multiple, serious major neurologic deficits including encephalopathy.

- Patient with extensive systemic disease and without reasonable systemic treatment

- 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.
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