WB-TT + cisplatin + gemcitabine + low-dose interferon-a
Protocol A













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 treatment.

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.

Created in the Division of Oncology at The University of Texas Houston Medical School
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Last updated on March 22, 2009
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