• Tumor response, disease-free survival [ Time Frame: 2 months to 5 years ] [ Designated as safety issue: No ]
  

• Allow inoperable pancreatic cancer to be converted to operable disease [ Time Frame: 2 months to 5 years ] [ Designated as safety issue: No ]
  

Once you are accepted for this study, you will need to have a central venous line (CV line or port) inserted if you do not already have one. (This may have this done by your own physician, or we would be happy to help you with this procedure).

The treatment cycle begins with 6 hours of intravenous (IV) hydration followed by an infusion of the anti-cancer drug, Cisplatin. In addition, at the beginning of this treatment, you will begin low-dose Interferon-alpha injections, once a day, for the entire duration of your participation in this study. The drug, Interferon-alpha, interrupts the division of cancer cells, destroys tumor blood vessels, and slows tumor growth.

Forty-eight hours after the Cisplatin infusion, you will be treated with fever-range thermal therapy (whole-body hyperthermia, or heat). When your core body temperature reaches 104oF (40oC), a 30-minute (IV) infusion of another chemotherapy drug, Gemcitabine (gemzar) is given. Cisplatin, low-dose Interferon-a and Gemcitabine are the only chemotherapy drugs used in this treatment plan. No other chemotherapy drugs are allowed to be given under this treatment plan.

The fever-range whole-body heat treatment is carried out while you are lightly sedated. With this sedation, you will be awake during the treatment but you will not be uncomfortable. This sedation is used to reduce any discomfort of the 6-hour heat treatment procedure yet will allow you to speak to your nurses.

Your body temperature is raised to 104oF (40oC) over a period of 60-120 minutes. When the body first reaches the target 104oF, we administer the Gemcitabine chemotherapy over 60 minutes and continue to maintain the 104 oF body temperature for six hours. At the conclusion of the six hours of thermal treatment, you will be cooled to your normal body temperature, which takes about 30-45 minutes. The entire treatment lasts approximately 8 hours. After the treatment is completed, we will observe you for 2 to 12 hours to make sure you have tolerated the treatment without a problem.

You will continue the daily low-dose Interferon-alpha. Additionally, you 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. White blood cells are important to help your body fight infection.

After treatment, you will need a complete blood count with platelet and differential count each week. These lab studies can be done at your own doctor's office or hospital as long as you make sure that the results are faxed to us. They can also be done in our clinic. We will see you again in approximately three to four weeks and the treatment cycle will be repeated.

We always attempt to perform at least two thermo-chemotherapy cycles. After the second treatment, CT and/or MRI scans are repeated to see if your cancer is smaller. 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 you respond to the treatment. There is no limit to the number of heat treatments a patient may have.