Clinical Trials: Revolutionizing Cancer Care
Steven A. Limentani, MD,
While Phase I studies may be conducted in healthy volunteers, it's un ethical to administer chemotherapeutic agents to healthy individuals. Thus a Phase I unit can be developed specifically to administer these agents to volunteers with cancer. Depending on the Phase I trial, patients being treated may be the first to receive the drug. Preclinical data from animal models provide a safe starting dose for patients and help identify expected toxicities. While extensive in vitro assays and in vivo animal studies help ensure safety, human studies are necessary to obtain a better understanding of a new drug’s effects on individuals. Many toxicities may be unanticipated and highly trained staff must be ready to respond. Patients may benefit by being the first to receive a novel agent that will ultimately affect their disease course.
In addition to specialized personnel, Phase I units must have complex monitoring capabilities that are more advanced than a standard chemotherapy infusion suite. Facilities must be available for processing and storing biospecimen samples in a timely fashion. In designing Morehead Medical Plaza II, the new home of Levine Cancer Institute, a specialized Phase I unit is being planned. To develop a state-ofthe-art facility, Institute representatives made site visits to the Dana Farber Cancer Institute in Boston and the Cancer Therapy and Research Center in San Antonio, two established leaders in Phase I oncologic investigation.
In an era where new treatments are developed daily, the Phase I unit of the Institute will serve as a regional center of excellence for patients to receive exciting new agents for cancer treatment.