Carolinas HealthCare System
Fall 2011

Clinical Trials: Revolutionizing Cancer Care

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Steven A. Limentani, MD,
Oncologist

PHASE I CLINICAL TRIALS ARE THE UNDERPINNING for the development of novel agents that will ultimately revolutionize the management of all types of cancer. Although some trials can be conducted in the standard treatment environment, they are best performed in specialized units that have the environment (physical space) and trained personnel to monitor patients closely. They can handle unanticipated toxicities, manage multiple blood draws and other evaluations to provide a comprehensive understanding of an agent’s toxicities, pharmacokinetics and pharmaco-dynamics as well as hints about efficacy to give direction for Phase II studies.

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.

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