Pilot Trial of Dose-Volume Constraints for Reirradiation of Recurrent Brain Tumors

In this study, you will be treated with radiation. The type of radiation used to treat you
will be determined by your doctor.

Radiation Therapy:

If you are found to be eligible to take part in this study, the dose of radiation will be
decided by your radiation oncologist, using guidelines developed for this study. The dose
will depend on your age, the type of tumor, your previous radiation treatment, and the amount
of time that has passed since your last course of radiation.

You will sign a separate consent form for radiation treatment that will describe how the
radiation will be administered and its risks in more detail.

Before beginning radiation, you will have what is called a "simulation" to plan your
radiation. During the simulation, you will be flat on your back on a computed tomography (CT)
table and a soft plastic mask will be made to help hold your head still during treatment.
This is the position you will be in when you receive radiation treatment. You will then have
a CT scan, which will make computerized images to help plan your treatment. This should take
about 15 minutes.

You will be given standard drugs to help decrease the risk of side effects. You may ask the
study staff for information about how the drugs are given and their risks.

Study Visits:

At Months 1, 3, 5, 7, 9, 11, 13, 16, 19, 22, and 25 after radiation therapy:

- You will have a physical exam.

- You will have an MRI to check the status of the disease.

- You will complete questionnaires about your quality of life and symptoms.

Starting 2 years after radiation therapy, the study staff will continue checking your medical
record to find out about your health status.

Length of Treatment:

You may receive up to 6 weeks of radiation therapy. You will no longer be able to receive
radiation therapy if the disease gets worse, if intolerable side effects occur, or if you are
unable to follow study directions.

Your active participation on the study will be over after the last study visit (about 25
months after your radiation).

Inclusion Criteria:

1. Previous pathologic confirmation of a tumor treated with radiation to the brain
completed at least 6 months prior to the start of planned reirradiation, except for
patients with tumors that are routinely diagnosed without biopsy, including germinoma
and optic pathway glioma. Patients with a history of cranial irradiation for leukemia
are eligible.

2. Patient must have received one and only one previous course of radiation to the brain,
delivered at 1.5 - 2.5 Gy/fraction, one fraction per day.

3. Multidisciplinary evaluation of the patient must be performed with a consensus
recommendation for reirradiation.

4. Patient may not receive concurrent chemotherapy with reirradiation, other than
temozolomide or bevacizumab given at the discretion of the treating neuro-oncologist.

5. Patient must have imaging findings within the last 3 months consistent with recurrent
disease in the brain. Pathologic diagnosis of recurrence is not required.

6. Patient may undergo surgical resection prior to reirradiation.

7. Dose-volume histogram data and cross-sectional imaging from previous radiation must be
obtained. Electronic dosimetry records in DICOM format from previous radiation are
strongly preferred.

8. Signed informed consent by patient and/or parents or legal guardian.

9. Lansky/Karnofsky Performance Status score of 50-100.

Exclusion Criteria:

1. Patients with recurrent diffuse intrinsic pontine glioma (DIPG)

2. Pregnancy