Trial Information

A Phase II Study of Total Skin Electron Beam Therapy (TSEBT) to Dose of 12 Gy in Stage IB-IIIA Mycosis Fungoides

Study Radiation:

During total skin electron beam therapy, radiation is given to the entire surface of the
skin. This may cause the cancer cells to die.

Researchers would like to learn the level of effectiveness of this lower dose of radiation
therapy because it is likely to have fewer side effects than the standard, higher dose.

Screening Period:

Signing this consent form does not mean that you will be able to take part in this study.
You will have the following "screening tests" to help the doctor decide if you are eligible
to take part in this study.

Within 6 weeks before the radiation therapy can begin:

- If the doctor thinks it is needed, you will have a computed tomography (CT) scan or
other type of scan to check the status of the disease.

- If the doctor thinks it is needed, blood (about 1 teaspoon) will be drawn to check for
cancer in your lymph nodes.

Within 4 weeks before the radiation therapy can begin:

- Your medical history will be recorded, including any drugs you are taking and have
taken.

- You will have a physical exam, including a skin exam and measurement of your weight and
vital signs (blood pressure, heart rate, temperature, and breathing rate).

- You will be asked how well you are able to perform the normal activities of daily
living (performance status).

- Blood (about 1 teaspoon) will be drawn for routine tests.

- Women who are able to become pregnant must have a negative urine pregnancy test.

The study doctor will discuss the screening test results with you. If the screening tests
show that you are not eligible to take part in the study, you will not be enrolled. Other
treatment options will be discussed with you.

Wash-Out Period:

If you agree to take part in this study, from that day until your first study radiation
treatment, you will stop certain treatments for mycosis fungoides. This is called a
"wash-out period". The number of weeks will be different depending on what treatments you
may be receiving. The study doctor will explain the types of treatments and schedule for
stopping them.

- For the 2 weeks before radiation, you will stop using any cancer drugs that are
"topical" (applied onto the skin).

- For the 4 weeks before radiation, you will stop any radiation therapy, phototherapy
(cancer treatments with light), cancer drugs that are "systemic" (affecting the whole
body), and any other investigational therapy.

Study Visit Before Radiation Therapy:

Within 1 week before your first radiation treatment, the following tests and procedures will
be performed:

-You will have a physical exam, including a skin exam and measurement of your weight and
vital signs.

Your performance status will be recorded.

- You will be asked about any drugs you may be taking.

- The doctor will draw on your skin with a marker to mark areas of your body that are
unexposed. This is to help plan the radiation treatments. Depending on your body
shape, about 8-16 body areas will be marked.

- Photos will be taken of your whole body. These photos will be used to help the doctor
find out how much skin is affected by the disease.

Radiation Treatments:

If you are found to be eligible to take part in this study, you will receive low-dose
radiation to the skin 4-5 days a week for 3 weeks.

On Mondays and Tuesdays, you will receive radiation that can cover your entire skin area.
You will be standing during the treatment. This wider-field radiation treatment cannot give
enough radiation to the unexposed areas of your body, such as under the arms, under the
breasts for females, under the belly, in the private areas, and the soles of the feet. For
this reason, in addition to the wider-field radiation, you will also receive radiation that
covers these smaller areas of your body on Wednesdays and Thursdays. The amount of
radiation that these smaller body areas will receive is designed to be the same as the
amount the rest of the skin will receive.

If the study doctor thinks it is needed for standard care, you will also receive radiation
treatments on other tumors. In most cases, this will be on Fridays. It will be 4-7
treatments, depending on the tumor size.

At Weeks 2 and 3 of radiation treatment, you will be asked about any side effects that have
occurred.

Length of Study:

You may receive up to 3 weeks of low-dose radiation therapy. You will be taken off the
study treatment early if intolerable side effects occur or the disease gets worse. The
follow-up period in this study lasts up to 12 months after the last treatment.

Follow-Up and End-of-Study Visits:

After your last dose of low-dose radiation therapy, you will have follow-up visits 1 to 3
weeks after treatment, every 2 months for 6 months, and then every 3 months for a total of
12 months. However, if the disease gets worse during this 12-month follow-up period, the
follow-up visits will stop. When you are off-study, an end-of-study visit will occur.

If you stopped the radiation early due to intolerable side effects, you will have follow-up
visits twice a week until the doctor thinks the side effects have gotten better. After
that, you will return for an end-of-study visit.

At the follow-up visits and end-of-study visit, the following tests and procedures will be
performed:

- You will have a physical exam, including a skin exam and measurement of your weight and
vital signs.

- Your performance status will be recorded.

- You will be asked about any drugs you may be taking and side effects that may have
occurred.

- Photos will be taken of your whole body to check the status of the disease.

- Blood (about 1 teaspoon) will be drawn for routine tests

This is an investigational study. For this type of cancer, the dose of radiation in this
study is lower than standard. The type of radiation therapy (total skin electron beam
therapy) is standard. At this time, the lower dose is only being used in research.

Up to 20 patients will be take part in this study. All will be enrolled at M. D. Anderson.