Hyperthermia
with ChemotherapyTo Treat Inoperable or Metastatic Tumors
Hyperthermia (heat) can
increase the effect of chemotherapy treatments. By itself, it can also kill cancer cells. By using heat to treat the whole body,
we can treat cancer cells wherever they are throughout the entire
body. In this study, we are testing
the combination of heat treatment and chemotherapy to see:
- If it improves the
effect of the chemotherapy drugs,
- If it helps the
body fight the cancer cells, and,
- If this treatment
is safe and pleasant for the patient.
This
study does not offer heat treatment alone.
Any patient with inoperable or metastatic neuroendocrin tumors (any
organ), gastric, cholangiocarcinoma, small-bowel, lung, head and neck, or
melanoma may be treated; however, the patient will need to undergo some
medial tests to make sure this treatment would be safe for them.
Once
you have been accepted for this study, the patient will need to have a
Central Venous line (CV line or port) inserted if they do not already have
one. (You may have this done by
your doctor or we would be happy to help you with this procedure as well.)
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 receiving low-dose Interferon-a
injections – once a day – for the entire duration of your participation in
this study. The drug, Interferon-a,
interrupts the division of cancer cells and slows tumor growth.
Thirty-six
hours after the Cisplatin infusion, the patient is treated with fever-range
thermal therapy (whole-body heat).
When the core body temperature reaches 104 degrees F (40 degrees C),
a 30-minute (IV) infusion of another chemotherapy drug, Gemcitabin (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 performed while the patient is
under light conscious sedation.
With this type of sedation, you will be awake during the treatment
buy you will not be uncomfortable.
This type of sedation method is used to reduce the discomfort of the
6-hours heat treatment procedure yet allows the patient to respond to
verbal commands.
The
patients’ body temperature is raised to 104 degrees F (40 degrees C) over a
period of 60-120 minutes. When the
body first reaches the target 104 degrees F, we administer the Gemcitabine
chemotherapy over 60 minutes and continue to maintain the 104 degrees F body
temperature for six hours. At the
conclusion of the six hours of heat treatment, the patient is cooled off to
their normal body temperature, which takes about 30 to 45 minutes. The entire procedure lasts approximately
8 hours. After the treatment is completed,
we observe the patient for 2 to 24 hours to make sure the treatment has
been well tolerated.
The
patient will continue the daily low-dose Interferon-a. Additionally, the patient will be given
daily Leukin (sargramostim) cytokine injections usually beginning 3 to 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 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 a patient again
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 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.
-National Cancer Institute
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