Trial Information

A Phase I Study of Continuous Hyperthermic Peritoneal Perfusion (CHPP) With Escalating Doses of Cisplatin for Children With Peritoneal Carcinomatosis or Advanced Peritoneal and Retroperitoneal Disease

Cisplatin has an atom at its center that contains platinum. The platinum is supposed to
poison the cancer cells, causing them to eventually die. Sodium thiosulfate is designed to
bind-up any Cisplatin that has escaped from the abdomen into the blood stream.

This is an investigational treatment which has been performed on two children on a
compassionate use basis in North America. Both surgeries were performed at M.D. Anderson by
the Study Chairman.

Before you can start receiving the study drugs, you will have "screening tests." These
tests will help the doctor decide if you are eligible to take part in this study. A
physical exam will be performed, and you will have a computed tomography (CT) scan, or
magnetic resonance imaging (MRI) scan to make sure the disease is only in the abdomen
(stomach area). Blood (about 1 teaspoon) will be drawn for routine tests. You may have an
echocardiogram (ECHO--a test to check heart function), and electrocardiogram (ECG--a test to
measure electrical activity of the heart) if you have ever taken an anthracycline drug. An
echocardiogram uses sound waves to make pictures of your heart, which helps show how well
your heart pumps blood. You will be asked to lie on your left side while a technician
places a probe with gel on your chest to create images of your heart to determine the
function and size. Women who are able to have children must have a negative urine pregnancy
test.

If you are found to be eligible, you will have a hearing test before your surgery and at
your one-month evaluation.

If you are found to be eligible, the abdominal surgery will be performed to try to remove as
many tumors as possible. The surgeon may decide during the surgery that the abdominal wash
will not be performed, for example if the disease has spread to or attached to certain
organs. If this occurs, your doctor will discuss other treatment options with you.

If the doctor decides that you are eligible to receive the abdominal wash, a drug called
sodium thiosulfate will be given through a needle in your vein. The abdomen will then be
temporarily closed. Then the abdominal wash will begin. This will be done in the same room
while you are under anesthesia. During the "abdominal wash," the heated cisplatin will be
given into your abdomen and will "wash" over the area of the surgical procedure. There will
be a pump attached to the plastic tubing and that will pump the drug in and out of your
abdomen during that 90 minute period while the surgeon is gently compressing your abdominal
wall so that the drug can reach all areas of your abdomen equally. After 90 minutes the
drug is removed and your abdomen is 'washed' with saline. Then all the fluid is removed and
the surgeon permanently closes your abdomen with 3 layers of stitches.

The actual dose level of cisplatin that you will receive will be decided when you enter the
study. Participants on this study will be enrolled in groups of 3, and each group will be
given a specific dose level of cisplatin. The first group will receive the lowest dose of
cisplatin. If there are no severe or life-threatening side effects in this first group of
patients, the next group will receive a higher dose of cisplatin and so on. This process of
increasing the dose level for each new group of participants will continue until some
patients have severe or life-threatening side effects. At that point, the dose level of
cisplatin will be lowered and tested again in more participants.

Blood (about 1 teaspoon) will be drawn for routine tests. This testing will take place
during the operation and every day until you leave the hospital.

After you leave the hospital, you will have a study visit about 1 month later, and then
every 3 months for 6 months. At these visits, you will have a CT scan or MRI scan and a
physical exam to check the status of the disease.

You will be taken off study if the disease gets worse or if you are disease free at or after
your 6 month follow-up.

This is an investigational study. Cisplatin is FDA-approved and commercially available. Up
to 18 patients will take part in this study. All will be enrolled at M. D. Anderson.