Trial Information

Phase II Study of Mild Whole Body Hyperthermia Combined With 5-Fluorouracil/Interferon-a/Liposomal Doxorubicin in Patients With Advanced Malignancy

Once a patient has been accepted for this study, the patient will need to have a Central
Venous line (CV line or port) if they do not already have one. (this may be placed by the
patient's own doctor, or it can be done here).

The treatment cycle begins with a continuous 24-hour intravenous infusion of 5-Fluorouracil
(5-FU) over a period of 5 days. This regimen will end 24 hours prior to the scheduled heat
treatment. In addition, at the beginning of the treatment, the patient will begin daily,
low-dose Interferon-alpha injections for the duration of their participation in this study.
The drug, Interferon-alpha, is given to stimulate the immune system and to decrease tumor
microvasculature. Interferon-alpha also interrupts the division of cancer cells and slows
tumor growth.

The fever-range whole-body heat treatment is performed while the patient is under light
conscious sedation. With this type of sedation, the patient is awake during the treatment
but not uncomfortable. This type of sedation method is used to reduce the discomfort of the
6-hour heat treatment procedure yet allows the patient to respond to verbal commands.

The patient's body temperature is elevated to 40oC (104oF) over a period of 60-90 minutes.
When the body reaches the target 40 oC, we will maintain that body temperature for six
hours. At the conclusion of the six hours of heat treatment, the patient will be cooled to
their normal body temperature, over 30-45 minutes. The Doxil chemotherapy will then be
infused i.v. over a period of 2 hours.

The entire procedure lasts approximately 8-10 hours. After the treatment is completed, we
observe the patient for 2 to 12 hours to make sure the treatment has been well tolerated.

The patient will continue the daily low-dose Interferon-alpha injections. Additionally, the
patient will be given daily Leukine (sargramostim) cytokine injections usually beginning 3-5
days after receiving chemotherapy to help support the immune system by helping the body
create more white blood cells, which are important in helping your body fight infection.

After treatment, the patient will need a complete blood count with platelet and differential
count each week. These lab studies can be done at the patient's own doctor's office as long
as the results are faxed to us. They can also be done in our clinic. The treatment cycle
will be repeated every 28 days.

We always attempt to perform at least two thermochemotherapy cycles. After the second
treatment, CT and/or MRI scans are repeated to see if the tumor has changed. These scans,
along with a physical examination and the lab studies, are used to determine if additional
heat treatments will be performed. Additional treatments continue based on how well a
patient responds to the treatment. There is no limit to the number of heat treatments a
patient may have.