Trial Information

A Phase II Clinical Trial of Cisplatin + Gemcitabine HCl (GEM) + Low-Dose Metronomic Interferon-a (IFN-a) Combined With Fever-Range Whole-Body Thermal Therapy (FR-WB-TT) in Patients With Metastatic/or Locally Advanced Malignancies (Small-Cell Lung Cancer, Neuroendocrine Cancer, Gastric Cancer)

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 that will continue for the entire
duration of your participation in this study. The low-dose Interferon-alpha interrupts the
division of cancer cells, kills blood vessels feeding the cancer, and slows tumor growth,
and as well boosts the body's immunity against the cancer.

Thirty-six hours after the cisplatin infusion, you will be treated with fever-range thermal
therapy (whole-body hyperthermia). The fever-range whole-body thermal therapy enhances the
effect of chemotherapy drugs against the cancer, and is thought to also boost your own
immune response against the cancer. When the core body temperature reaches 104oF (40oC), a
30-minute (IV) infusion of another chemotherapy drug, gemcitabine (Gemzar) is given.
Cisplatin, low-dose interferon-alpha and gemcitabine are the only chemotherapy drugs used in
this treatment protocol. No other chemotherapy drugs are allowed to be given under this
treatment plan.

The fever-range whole-body heat treatment is performed while you are lightly sedated. With
this type of sedation, you are awake and can talk during the treatment but you are not
uncomfortable. This type of sedation method is used to reduce any discomfort of the 6-hour
heat treatment procedure yet allows you to talk to the nurses.

Your body temperature is raised to 104oF (40oC) over a period of 60-120 minutes. When your
body first reaches the target 104oF, we administer the gemcitabine chemotherapy over 60
minutes and continue to maintain the 104oF body temperature for six hours. At the
conclusion of the six hours of thermochemotherapy, you will be cooled off 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.

You will continue the low-dose Interferon-alpha injections once weekly. Additionally, you
will be given 5-10 days of Leukine (sargramostim, GM-CSF) injections beginning 3-5 days
after receiving chemotherapy to help support your immune system by helping your body create
more white blood cells, which are important in helping 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 your
response to the treatment. There is no limit to the number of heat treatments a patient may
have.