This study is for patients with breast, cervical, endometrial or ovarian cancer 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 (40^oC), whole body thermal therapy (FR-WB-TT) with a chemotherapy regimen of 5-fluorouracil (5-FU), liposomal doxorubicin (trade name Doxil) and low-dose interferon-alpha (IFN-a). The treatment is administered on an out-patient basis.

After staging diagnostic studies have been completed, the thermo-chemotherapy treatment cycle begins with a continuous intravenous infusion of 5-Fluorouracil (5-FU), 24 hours a day, for 5 days. During this same time period, the patient will also receive low-dose IFN-a injections once a day for the duration of the protocol. The IFN-a is given to stimulate the immune system, and as an anti-angiogenesis agent. 24 hours after the 5-FU infusion ends, FR-WB-TT treatment begins. Doxil is given by injection one hour after the end of the FR-WB-TT treatment. 5-FU, Doxil and IFN-a are the only chemotherapy drugs used in this treatment.

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 Doxil is injected over a period of two hours, beginning 1 hour after the end of the FR-WB-TT treatment. The entire procedure lasts approximately 8-9 hours. Afterward, the patient is observed for 2 to 24 hours so we can confirm that the patient has tolerated the treatment without difficulty.

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 FR-WB-TT will be performed. There is no set limit to the number of FR-WB-TT treatments a patient may have. Continued treatments are based on patient response and are performed at Dr. Bull's discretion.