Ultra Low Dose Radiation for Local Treatment of Cutaneous Mycosis Fungoides

Radiation Treatment:

Radiation will be applied directly to the lesion on the skin. A lower energy form of
radiation will be used that mostly affects only the first inch of skin. The doctor will use a
marker to mark the area of the skin that needs to be treated. The radiation team will then
perform a calculation that determines how long your treatment will last to deliver the right
dose of radiation. The radiation will then be delivered by a certified radiation therapist
using a radiation treatment machine.

Study Visits:

About 4-6 weeks after completion of radiation, you will have a skin check, and a photograph
will be taken of the affected area. If you are unable to make this appointment, you may
submit an electronic photograph taken during this time interval or bring a photograph with
you to your next follow up visit. You will also complete the symptom questionnaire.

About 10-14 weeks after completion of radiation, you will complete the symptom questionnaire
again. If you are unable to come to this visit you will be asked to take pictures of the
affected area(s) at home with a ruler or standard-sized object, like a penny. The
questionnaire will be done over the phone, and you may be asked additional questions about
the affected area(s).

After this, you will be scheduled to follow up again around 6-8 months after you finish
treatment, then every 6-12 months until it has been about 2 years since you completed
radiation. At these visits:

- You will have photographs taken of the affected area(s).

- You will complete the questionnaire about your symptoms.

Additional visits may be scheduled if the doctor thinks it is needed.

Length of Study Participation:

You will be on study for about 2 years, or as long as the study doctor thinks it is in your
best interest. You will no longer be able to take part if intolerable side effects occur or
if you are unable to follow study directions.

After your participation in the study has ended, the photographs taken of you may be used in
future studies or in future publications. If so, every attempt will be made to edit the
photographs to remove any features that could be used to identify you.

If you leave the study and the study doctor thinks it is needed, you will receive the
standard dose of radiation. In that case you will sign a separate consent that explains the
procedure, as well as its risks.

Inclusion Criteria:

1. Patients 18 years or older at presentation with pathologically confirmed MF with
cutaneous involvement. *Patients must have clinically measurable disease of at least 1
lesion on physical (skin) exam. *If a patient has a prior pathological diagnosis of MF
and is clinically diagnosed with a new lesion, the new lesion is eligible for
enrollment without additionally biopsy confirmation.

2. Lesions of any surface span as long as skin surface for which local control is desired are eligible; a single patient may
have multiple eligible lesions that are individually enrolled for the study.

3. All stages of disease (IA through IVB) where radiation therapy is being considered for
local control are eligible. Patients who are concomitantly undergoing systemic therapy
for more advanced stage disease are eligible.

4. Patients who are concomitantly undergoing systemic therapy for more advanced stage
disease are eligible.

5. Female patients of childbearing potential must have a negative serum pregnancy test
(betahCG) within 2 weeks of protocol entry if the patient is unsure of their pregnancy
status. Patient signature declaring that they are not pregnant on the informed consent
for treatment that is used in the Department of Radiation Oncology is also an
acceptable substitution for a serum pregnancy test.

6. Patients who are receiving or are planned to start topical chemotherapeutics,
retinoids or imiquimod to other lesions that are not planned for enrollment are
eligible; however, the lesion being considered for enrollment should not be under
active therapy with these topical agents immediately prior to enrollment. * Use of
topical chemotherapeutics, retinoids or imiquimod on the lesion that is a candidate
for enrollment must be halted at least 24 hours prior to enrollment in the study.

Exclusion Criteria:

1. Pregnant patients do not meet inclusion criteria for radiation therapy. *Patients who
subsequently become pregnant may continue follow up within the protocol, but a
negative urine pregnancy test will need to be obtained before additional lesions may
be enrolled.

2. Patients with active lupus or scleroderma

3. Lesions with a height >1 cm measured from the skin surface are not eligible for this
protocol.