A Nontoxic System for 41.8°C Whole-Body Hyperthermia: Results of a Phase I Study Using a Radiant Heat Device

A Phase I study of whole-body hyperthermia (WBH) (52 treat ments/12 patients) was completed with no significant clinical toxicity. The study incorporated a thermal dose escalation scheme from 39.5°-41.8°Cfor up to 151 min. A radiant-heat device was utilized for producing WBH. During WBH, patients were sedated; endotracheal intubation was not required. No changes in cardiovascular, respiratory, hematological, or bio chemical indices requiring clinical intervention occurred during the study. We conclude the radiant-heat device coupled with a defined pharmacological approach to WBH with appropriate patient screening yields a system for 41.8°CWBH which is safe and efficient, is not labor intensive, and does not require general anesthesia and endotracheal intubation. This system is appro priate for a multimodality approach to various systemic cancers.