Proton Craniospinal Irradiation With Bone Sparing to Decrease Growth Decrement From Radiation

This research study is a Pilot Study to determine whether using proton therapy in
participants that require craniospinal radiation (whole brain and spinal cord radiation
therapy) with sparing of the bony spine will work. This is the first time investigators are
examining bone sparing proton therapy in pediatric craniospinal radiation.

The FDA (the U.S. Food and Drug Administration) has not approved proton radiation for this
specific disease but it has been approved for other uses.

In this research study, the investigators are studying proton radiation in participants that
require craniospinal radiation. The standard of care for this procedure is photon radiation,
which is very similar to proton radiation. The investigators believe that the precision of
proton radiation may help to reduce the negative effects radiation has on the surrounding
non-cancerous growing and developing tissue

Inclusion Criteria:

- Age ≥ 3 years and ≤ 18 years at the time of registration

- Histologically proven malignancy necessitating cranio-spinal irradiation. This will
include patients with a diagnosis of medulloblastoma, Supratentorial primitive
neuroectodermal tumor (SPNET), germ cell tumor (GCT), disseminated ependymoma,
embryonal tumor with abundant neuropil and true rosettes (ETANTR), Atypical
Teratoid/Rhabdoid Tumor (ATRT), and disseminated low-grade glioma (LGG).

- Life expectancy ≥ 12 months.

- Signed informed consent document and assent when appropriate.

- HGB of > 10 g/L and PLT count > 80 K/uL

Exclusion Criteria:

- Any prior therapeutic radiation therapy > 500 cGy has been delivered.

- Individuals with a history of a different malignancy are ineligible except for the
following circumstances: if they have been disease-free for at least 5 years and are
deemed by the investigator to be a low-risk for recurrence of that malignancy; or,
have had only cervical cancer in situ, or basal cell or squamous cell carcinoma of the
skin.

- Any major uncontrolled or poorly controlled intercurrent illness that would limit
compliance with study requirements.

- Pregnant females are excluded. Females of childbearing age/menstruating must confirm
that either they are not sexually active or have a negative pregnancy test prior to
initiation of radiation therapy.

- Patients that receive concurrent chemotherapy with the exception of concurrent
Vincristine.