This study is for patients with one of a variety of measurable, inoperable cancers including gastric, liver, lung, head and neck cancer as well as melanoma and cholangioma, whose pre-testing demonstrates that they have met the eligibility requirements. It follows a Phase II, non-randomized design such that all enrolled patients will receive long duration (6h), fever-range (40oC), whole body thermal therapy (FR-WB-TT) with a chemotherapy regimen of cisplatin, gemcitabine, and low-dose interferon-alpha (IFN-a). The treatment is
administered on an out-patient basis.
After the diagnostic studies have been done, the thermochemotherapy cycle begins
with the patient receiving 6 hours of hydration followed by an I.V. infusion
of cisplatin. During this same time, the patient also receives low-dose interferon-a injections once a day for the entire duration
of the protocol. The interferon-a is given to stimulate the immune system, and as an antiangiogenesis agent. Forty-eight (48) hours after the cisplatin infusion, the
patient receives a FR-WB-TT treatment. When the core body temperature has
reached 40oC (104oF), a 30-minute I.V. infusion of
gemcitabine (trade name Gemzar) is given. Cisplatin, gemcitabine and interferon are the only chemotherapy drugs that are used in this treatment plan. No other chemotherapy drugs are allowed in this treatment protocol.
The FR-WB-TT is performed under light conscious sedation. Our goal is to give the patient enough sedation to reduce the
discomfort of the 6 h of FR-WB-TT, but allow the patient to remain responsive to verbal commands. The
sedatives minimize patient discomfort and provide a partial amnesia effect
for the actual thermal therapy treatment. The patient is awake during the procedure. Over a period of 60-90 minutes the patient's body temperature is
raised to 40.0 oC (104 oF). Once this core body temperature is achieved it is maintained for six
hours. At the conclusion of the six hours of heat treatment the patient is cooled to normal body temperature
over 30-45 minutes. The entire procedure
lasts approximately 8 hours. Afterward, the patient is observed for 2 to
24 hours so we can confirm that the patient has tolerated the treatment
without difficulty. A
second dose of gemcitabine chemotherapy is given, usually by the patient's own
oncologist, a week after the fever-range whole-body hyperthermia/gemcitabine
Most patients are given daily Leukine cytokine injections, usually beginning a week after
receiving chemotherapy, to boost the white blood cell count. Because of specific immune-enhancing effects of Leukine on dendridic cells, we prefer Leukine (sargramostim) to Neupogen (filgrastim).The patient will need a complete blood count with platelet
and differential count each week after treatment. These lab studies may be done at a local doctor's office or
hospital provided the results are faxed to Dr. Bull. We try to work closely with the patient's local physician as we prefer the local physician to complete interim blood studies
and to FAX us the blood study results. Dr. Bull will see the patient again in approximately three to four
weeks and, if appropriate, the treatment cycle will be repeated. Please note that with
subsequent cycles there is considerably less diagnostic work up.
We always try to
perform two thermochemotherapy cycles. After the two treatments, staging
radiological studies are repeated. These studies, along with the patient's history, a physical examination performed by Dr.
Bull, and the lab studies, are used to determine whether additional cycles of WB-TT will be performed. There
is no set limit to the number of WB-TT treatments a patient may have. Continued treatments are based on patient response and are performed at Dr. Bull's discretion.