Cancer treatment developed in Department of Surgery approved for clinical trials

LEXINGTON, Ky. (Aug. 28, 2015) – The Food and Drug Administration (FDA) approved clinical trials for an investigational cancer treatment pioneered by University of Kentucky researchers in the Department of Surgery.
The Exatherm Total Body Hyperthermia System (Exatherm-TBH) was developed at UK in a public-private partnership with Exatherm, LLC, explained medical researcher Cherry Ballard-Croft, Ph.D. The project received grant funding from the National Institutes of Health.

Dr. Croft is a member of a Cardiothoracic Surgery research team at UK who developed this approach. Other members include Dr. Dongfang Wang, UK Artificial Organ Laboratory Director; Dr. Jay Zwischenberger, UK Department of Surgery Chair; Dr. Jeremiah Martin, Surgical Director of the Markey Cancer Center’s Multidisciplinary Lung Cancer Clinic; and Dr. Kevin Hatton, Chief of Anesthesiology Critical Care at UK.
Exatherm-TBH system is designed to elevate blood temperature throughout the body. Research has shown that heat can damage or even destroy specific types of cancer cells, leaving them more susceptible to radiation treatments and chemotherapy, Croft explained. Normal cells can withstand the heat insult because of their evolved heat protective mechanisms.
Whereas most thermal treatments are specific to the area of the body where a tumor is located, University of Kentucky researchers are examining a form of heat treatment that impacts the entire body using a minimally invasive procedure which involves a double-lumen cannula, invented and patented by Drs. Wang and Zwischenberger, and a heat transfer unit.
“The effectiveness of this type of system-wide hyperthermia has never been examined before,” commented Zwischenberger.
Preliminary safety studies on animals have shown that a gradual rise in blood temperature has no adverse effects on healthy cells or brain activity, which, according to Croft, is a key concern when dealing with thermal treatments on the circulatory system.
After the procedure was deemed safe, the FDA and University of Kentucky regulatory bodies gave approval for researchers to design a Phase 1 clinical trial for patients. UK is the only site in the country approved to test this treatment on patients with advanced lung cancer. Drs. Martin and Hatton will lead those trials.
“Potential candidates must have completed standard therapy and exhausted additional conventional options before being considered eligible,” said Dr. Martin.
The goal in any cancer treatment is to attack diseased cells and leave healthy ones alone.  Normal cells have a signaling mechanism that protects them from increases in body temperature. This mechanism is defective in cancer cells, which the potential new treatment aims to exploit, Martin said.
The treatment, which lasts approximately four hours under a general anesthetic, uses the Exatherm-TBH System to heat and circulate the blood throughout the body. The device heats the patient’s blood to a temperature of 42 degrees Celsius, or about 107 degrees Fahrenheit.
Because systemic hyperthermia attacks cancer cells throughout the body all at once, the research team hopes the project will lead to a new and safe method for treating patients whose cancer has metastasized through the body.
"If results meet our expectations, the approach would present an advantage over other methods of thermal treatment, particularly in later stages of the disease," said Martin.