Trial Information

Phase IV GliaSite® Radiation Therapy System Registry Protocol for the Treatment of Resectable Malignant Brain Tumors

Your doctor has found that you have a brain tumor that needs to be surgically removed. Your
doctor has explained the risks and benefits of the surgery. After the brain tumor is
surgically removed, some tumor may be left. A treatment that sends additional radiation
right to the place around where the tumor was located, may help kill any tumor cells left
after the surgery. This treatment is called brachytherapy. Your doctor has explained the
risks and benefits of brachytherapy. Researchers in this study would like to evaluate a
radiation delivery system, GliaSite RTS, that provides brachytherapy targeted to a specific
site in the brain, to see its effects to the surrounding area where the tumor was located.

The GliaSite RTS is a balloon attached to the end of a tube with an access port. The balloon
will be put in the space left behind after your tumor is taken out. The end of the tube with
its access port will be on the outside of your skull, underneath the skin, at the top of
your head. The balloon is filled with radiation therapy solution to provide radiation
therapy to any remaining tumor cells next to the space where the tumor was removed.

Before your already scheduled surgery, a series of tests will be performed to find out if
you qualify for participation in this study. You will have a complete medical history and
your temperature, blood pressure, and pulse will be measured. A standard neurological exam
will be performed, in which your mental status, vision, sensory functions, speech, motor
skills, and functioning will be evaluated. Women who are able to have children must have a
negative urine or blood pregnancy test. A MRI/CT scan will be taken of your head. As part
of this MRI/CT, you will get an injection of a contrast solution into your vein. The MRI/CT
images will show if there is brain swelling or bleeding. It will also show the edges of the
tumor area and will be used to confirm that you should receive radiation therapy with the
GliaSite RTS.

If you qualify for the study, you will have a small balloon (GliaSite) placed in the space
where the tumor was removed during your surgery. The balloon will be filled with an x-ray
dye and normal saline (sterile water with salt) to make sure that the balloon properly fills
the space where the tumor was removed. Your surgeon will then stitch your head closed. It
is possible that your surgeon may decide not to place the GliaSite device in the space where
the tumor was. If your surgeon chooses not to place the GliaSite device, you will be
offered alternative treatments, once you recover from surgery.

The balloon will be filled with an x-ray dye solution once it has been placed in the
surgical cavity and will be kept filled until it is replaced by the radioactive solution.
You will then have an MRI/CT of the head. Following this MRI/CT exam, you will get an
injection of a contrast solution into your vein. You will then have a second MRI/CT exam of
the head, which will show this contrast solution. The MRI/CT images will show if there is
brain swelling or bleeding. It will also show the edges of the tumor area and where the
balloon is located. These images will be used to confirm that you should receive radiation
therapy with the GliaSite RTS device. You may also have x-ray films of the brain to confirm
balloon placement. You may be able to leave the hospital after surgery.

You may be readmitted to the hospital for radiation therapy about one to two weeks after
surgery. Twenty-four hours before starting radiation therapy, you will begin taking a
medication and continue taking it for 24 hours after your radiation therapy is finished.
This medication, an iodine-potassium iodide solution, keeps your thyroid gland from
gathering too much radiation in the event that the balloon leaks.

Before the radiation therapy is begun, x-ray films of the brain may be taken to show the
location of the balloon and verify the balloon is still properly placed. Once the placement
of the balloon is confirmed, the x-ray dye and saline are removed from the catheter. The
balloon will then be filled with radiation therapy solution and normal saline.

You may be able to go home once the material has been put into the balloon. If this is
done, special instructions will be given to you that you must follow if you are sent home.
You must then return to the hospital at the appropriate time for removal of the radioactive
material. Otherwise, you will be in the hospital the entire time you are getting radiation
therapy.

When the radiation therapy is completed after about 3 to 7 days, the radiation therapy
solution will be removed from the balloon. The GliaSite device will be rinsed with normal
saline. This rinsing helps lessen any radioactivity remaining in the device. After
completion of brachytherapy, the balloon will be completely emptied and the GliaSite device
will be surgically removed. When your doctor feels that you are ready, you will be
discharged from the hospital.

Following the completion of brachytherapy, you may receive other forms of radiation therapy
as prescribed by your physician. This is usually done as an outpatient.

You will be asked to follow up with your doctor at certain time points after you receive the
brachytherapy treatment. The time points are 1 month and 3 months after brachytherapy and
then every 3 months after that (for example, 1, 3, 6, 9, 12, 15, 18, 21 and 24 months).

During these follow up visits, you will be asked to complete a mini-mental status
examination referred to as a MMSE. You will be asked to complete a quality of life
questionnaire. Your physician may take an MRI or CT image of your brain if he/she thinks it
is necessary.If you have undergone a second operation for your brain cancer, you will be
asked about this surgery. You will be asked about any steroid medication you are taking and
if the dose has changed since your last visit. Your doctor will also ask you about any
other cancer medications or treatments you have received since your last visit.You and your
doctor may discuss any serious events that have happened to you since your last visit.

This is an investigational study. The device is FDA approved. About 300 patients will take
part in this multicenter study. Up to 20 will be enrolled at M. D. Anderson.