Collaborating for a Cure

Cancer therapy has come a long way. If you ask David Gaffney, MD, PhD, though, he’d say today’s researchers are “pleased but not satisfied” by the efficacy of contemporary treatments. Gaffney is principal investigator on a grant awarded in 2014 that will facilitate Huntsman Cancer Institute (HCI) and other national cancer institutions in the quest for a cure. The key to this initiative? Clinical trials and collaboration.

Clinical trials are research studies that test safety and effectiveness of new treatments. They benefit cancer care by giving patients access to new treatments before they are widely available. When cancer centers around the country team up or collaborate on a trial, a larger and more diverse group of patients is able to enroll. This increase in source data, in conjunction with an increased number of researchers analyzing it, can increase the study’s potential. Think “two heads are better than one” on a national scale.

In June 2014, the National Institutes of Health (NIH) awarded Gaffney and a team of HCI researchers nearly $3.6 million over the next five years to establish a Network Lead Academic Participating Site (NLAPS). Institutions with NLAPS awards—fewer than 40 in the country—work with NIH to create a new National Clinical Trials Network (NCTN).

Phases of Clinical Trials

Phase I: The first step in testing a new treatment in humans. These studies test the best way to give a new treatment (for example, by mouth, IV infusion, or injection) and the best dose. Because little is known yet about the possible risks and benefits of the treatment, these trials usually include only a small number of specific patients.

Phase I/II: Studies the safety, dosage levels, and response to a new treatment.

Phase II: Tests whether a new treatment has an anticancer effect (for example, whether it shrinks a tumor or improves blood test results) and whether it works against a certain type of cancer.

Phase III: Compares results of people taking a new treatment with results of people taking the standard treatment (for example, which group has better survival rates or fewer side effects). In most cases, studies move into phase III only after a treatment works in phases I and II. These trials may include hundreds of people.

Phase IV: Once a treatment is approved, side effects are evaluated in a very large group of people (usually thousands).

The NCTN will transform, consolidate, and integrate efforts of the previous National Cancer Institute (NCI) Clinical Trials Cooperative Group. The new network’s goals include developing multi-institutional clinical trials to evaluate new cancer therapies across a broad range of patient populations and cancer types.  

“Having an NLAPS enables HCI to participate fully in NCTN studies,” says Gaffney, who is vice chair, medical director, and professor of radiation oncology at the University of Utah School of Medicine and an HCI investigator and physician. “The goal is efficiency and cross-collaboration between scientists and physician-researchers so patients can access the best trials.”

According to Gaffney, HCI, an NCI-Designated Cancer Center, will be a significant asset in updating the NCTN and expanding the impact of national clinical trials. HCI enrolls about 20% of new patients in trials and has a long history of participating in high-level cooperative groups such as SWOG (formerly the Southwest Oncology Group) and the Gynecologic Oncology Group (GOG).

HCI also has a robust clinical trials infrastructure already established as well as unique research assets, including an NCI Center for Quantitative Imaging Excellence and the Utah Population Database.

“HCI is greatly invested in trials,” Gaffney explains. “Researchers here can open studies efficiently, have several studies open at once, and accurately track the patients enrolled. There is a collegial atmosphere to improve cancer therapies here—and it’s infectious.”

The NCTN is a forum in which HCI can share this perspective with similarly driven institutions and focus on late-phase trials (see sidebar). Studies in these phases will compare new drugs and therapies to see which are most effective.

“Testing one treatment against another is how we raise the bar and cure more patients,” says Gaffney. “The NCTN will allow us to do this in a fair and balanced, but rigorous, way.”