This program of projects emphasizes the clinical evaluation of hyperthermia combined with radiotherapy and chemotherapy in treatment of cancer. The program is a collaboration between Duke University Medical Center and the North Carolina State University that utilizes resources of both institutions. Tumor response, duration of response, survival, and normal tissue toxicity are study endpoints in protocols involving humans and canines with spontaneous malignancy. These protocols include, (1) teleradiotherapy with localized hyperthermia in canines with localized extracranial malignancy (Phase II), (2) whole body hyperthermia and cisplatin in canines with extracranial solid tumors (Phase I), and (3) localized and regional hyperthermia combined with radiotherapy or cisplatin in humans (Phase I/II). Study endpoints will be related to temperatures-time distributions that are measured as well be related to temperature-time distributions that are measured as well as modeled through numerical simulation of bioheat transfer. Quantitative, absolute measurements of blood perfusion distributions, essential for the latter simulations, will be measured serially in humans and animals using positron emission tomography. Development of microwave hyperthermia equipment to improve therapy in selected sites of disease is included in an Engineering Core. Core support for biometry and administration is provided. Animal patients are provided through another core, the Animal Core. The overall program goals are to develop a measure of thermal dose that correlates with biological and technical aspects of cancer treatment with hyperthermia, to develop innovative cancer therapy approaches through use of a canine animal model, and to conduct high quality human phase I/II trials involving hyperthermia.
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