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



Status:Recruiting
Healthy:No
Age Range:10 - Any
Updated:3/10/2019
Start Date:April 26, 2018
End Date:April 2020
Contact:T. Jonathan Yang, MD, PhD
Email:yangt@mskcc.org
Phone:212-639-8157

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A Phase Ib Study With Dose Expansion Cohort of Proton Craniospinal Irradiation for Leptomeningeal Metastases From Solid Tumors

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.


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
method.

- Adequate bone marrow function:

- Hemoglobin ≥ 8g/dL

- Absolute neutrophil count ≥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
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.
We found this trial at
8
sites
1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: T. Jonathan Yang, MD, PhD
Phone: 212-639-8157
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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