Novel methods of using hyperthermia with new drug delivery and gene therapy approaches takes this program to a new level with regard to potential clinical uses for hyperthermia.
The four main areas of current research efforts range from basic science investigations in the laboratory to the design of new heating equipment and cooperative phase III clinical trials to test the value of concepts and principles developed in the laboratory. More than 70 researchers participate in a collaborative effort led by Duke University and including North Carolina State and Colorado State Colleges of Veterinary Medicine.
This protocol is designed for patients with newly diagnosed soft tissue sarcomas who have had no prior treatment. Metastatic disease does not exclude enrollment provided a minimum life expectancy of at least 6 months is estimated. Patients must have an intermediate to high grade soft tissue sarcoma (grade 2 or 3). Treatment involves chemotherapy (Ifosfamide) followed by external beam radiation with hyperthermia, followed by surgery and additional postoperative chemotherapy (Adriamycin). Chemotherapy could be optional upon recommendation from the treating physician.
Randomized study comparing neoadjuvant chemotherapy (Etoposide plus Ifosfamide plus Adriamycin (EIA)) combined with regional hyperthermia vs. neoadjuvant chemotherapy alone in the treatment of high risk soft tissue sarcoma in adults.
This is a phase III trial which we are conducting in collaboration with several European hyperthermia centers. Patients with sarcomas located on the extremities, body trunk or retroperitoneum are eligible. Patients must have intermediate or high grade tumor histology. Patients who have received prior chemotherapy are not eligible. Patients with distant metastases are not eligible. This is a randomized study which means there is a 50% chance that you may receive the chemotherapy, radiation and surgery treatment without hyperthermia. This study is designed to test whether the addition of hyperthermia improves the local control or overall survival, without increasing morbidity of standard treatment.
"Hyperthermia boosts the killing power of radiation and chemotherapy by up to 10 times greater than without heat," says researcher Mark Dewhirst in a Duke University press release. Heating tumors before radiation treatment has been shown to shrink the tumors completely in more patients than radiation treatment alone, according to a study by Duke Comprehensive Cancer Center radiation oncologists. The study found that combined therapy shrank tumors completely in 66 percent of patients with cancers in the breast, chest wall, head and neck, and skin (melanoma). By contrast, radiation alone caused full tumor shrinkage in 42 percent of patients.
Most normal tissues are not damaged during hyperthermia if the temperature remains under 111°F. However, due to differences in tissue density, higher temperatures may occur in various spots. This can result in burns, blisters, discomfort, or pain. Most side effects are temporary. Whole-body hyperthermia can cause more serious side effects, including cardiac and vascular disorders, but these effects are uncommon. Diarrhea, nausea, and vomiting are commonly observed after whole-body hyperthermia.
Although hyperthermia is clearly an effective treatment option, variations in instrumentation and clinical study techniques has slowed hyperthermia’s widespread use as a stand alone method of care.
Whole Body Hyperthermia raises body temperature above normal. Though it does not directly kill tumor cells, it can be used along with chemotherapy to increase its effectiveness.
External heat treatment uses applicators positioned around or near the appropriate region, and energy is focused on the tumor to raise its temperature.
Intraluminal or endocavitary methods may be used to treat tumors within or near body cavities, such as the esophagus or rectum. Probes are placed inside the cavity and inserted into the tumor to deliver energy and directly heat the area.
Interstitial techniques are used to treat tumors deep within the body, such as brain tumors. This technique allows the tumor to be heated to higher temperatures than external techniques. Under anesthesia, probes or needles are inserted into the tumor while imaging, such as ultrasound, CT or MRI, may be used for proper probe positioning inside the tumor. The heat source may then be inserted into the probe.
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Radiofrequency ablation (RFA) is a type of interstitial hyperthermia that uses radio waves to heat and kill cancer cells.
Magnetic thermal ablation uses metallic nanoparticles (biocompatible superparamagnetic nanoparticles) which are excited to produce heat by an external magnetic source.