Skip to main content

UNC Lineberger secures three major NCI grants to advance the nation’s clinical trials program.

image2
Dr. Carey Anders, above consulting one of her patients, is one of many UNC Lineberger members leading clinical trials.

Advances in cancer care are impossible without clinical trials. Whether the treatment is a new chemotherapy or radiation, a surgical procedure, a new way to detect disease or a combination of these things, at some point it has to be tested on people in a clinical trial. And for patients like Tomma Hargraves, they are a lifesaver. “After being diagnosed with Stage 3B non-small cell lung cancer in 2006, I decided to participate in an aggressive clinical trial at UNC Lineberger. It included chemo, radiation and targeted oral medication for my particular type of lung cancer and lasted nearly nine months. By August of 2007, I was in remission.”

With three new grants awarded by the National Cancer Institute (NCI), UNC Lineberger is changing the face of clinical trials at the national level. Based on an Institute of Medicine report, NCI altered its entire approach to clinical trials. They set up a competition to find the best centers to lead the new effort. UNC Lineberger was one of only five sites that received all three grants.

By definition, a clinical trial is a research study that involves patients. And despite the fact that clinical trials are usually testing a “new” drug or treatment, the clinical trial itself is towards the end of a long testing process that involves multiple pre-clinical steps. When trials involve patients, they are divided into three main categories — Phase I, Phase II, and Phase III. In Phase I trials, also known as “Early Phase”, researchers are testing the optimal dose of a treatment to avoid toxic effects in the patient. Once a trial moves on to Phase II, researchers are then testing to see if the drug works against a specific type of cancer. Finally, at Phase III, the trial is testing how the new treatment compares to the current “standard of care” for the particular type of cancer.

At the national level, clinical trials are seeing a lot of change. In an effort to increase efficiency and keep up with national changes in the types of clinical trials offered to cancer patients, the National Cancer Institute’s (NCI) National Clinical Trials Network (NCTN) is undergoing a major reorganization. The new structure is meant to improve treatment for the more than 1.6 million Americans diagnosed with cancer each year and UNC Lineberger will be playing a major role in this transition.

The NCI awarded grants related to the new clinical trials infrastructure in the spring of 2014, and UNC Lineberger secured three major new grants as a part of this initiative. “Receiving one of these awards is an important accomplishment,” said UNC Lineberger Director Ned Sharpless, MD. “Receiving all three is truly remarkable, placing UNC Lineberger among only a small handful of cancer centers in the country with such success.” Through these grants, UNC Lineberger will be providing scientific leadership into the development of the new network, will be working to accelerate drug delivery in early Phase I trials and will also be providing genetic sequencing in support of NCTN.

As a part of the first grant, UNC Lineberger will serve as one of 30 NCI Lead Academic Participating Sites (LAPS) from across the country. Under the guidance of Dr. Lisa Carey, UNC Lineberger will provide NCI with scientific leadership in the development and implementation of clinical trials.

The cancer center also secured entry into an elite network focused on experimental clinical trials — the NCI’s Experimental Therapeutics Clinical Trials Network. Led by Dr. Claire Dees teaming with trialists at Duke and Washington University, UNC Lineberger will conduct early phase cancer clinical trials sponsored by the NCI to help speed the drug development process.

“Almost 1,600 people die from cancer every day in this country,” said Dees. “We need to rapidly develop new drugs, focusing on targeted therapies that address the genetics and biology of this disease. Bringing together the excellent science and clinical care of three great cancer centers, we hope to make oncology drug development smarter, faster and more successful.”

Lastly, UNC Lineberger is one of only five institutions across the country receiving a new grant to measure biomarkers within the NCTN as an Integrated Translational Science Center (ITSC). Spearheaded by Drs. Chuck Perou and Neil Hayes, the UNC ITSC will provide high-throughput RNA and DNA sequencing, along with related regulatory assistance, to partner institutions in the NCTN. Earning this distinction clearly acknowledges UNC Lineberger as one of the world’s foremost centers for high volume, clinical genetic sequencing.

Cancer patients across the country, especially those in North Carolina, will greatly benefit from the new trials as well as the clinical and translational science being provided by UNC Lineberger as clinical trials evolve at the national level.