The Great Unknown

An exploration into the UF health Cancer Center clinical trials network

By Morgan Sherburne

Each year, more than 1,000 patients take part in clinical trials at the UF Health Cancer Center. Contrary to belief, not all of these patients are testing a new cancer therapy. Some provide genetic information about a particular kind of cancer; others donate samples of their cancer cells. Some patients help clinicians reduce the severity of treatment side effects; others will test new ways of detecting cancer early.

But all are helping UF researchers chip away at the great unknown: what makes each person’s cancer tick, and how to stop that ticking without causing harm to the patient over the course of treatment.

For the past three years, John Wingard, M.D., the deputy director for research at the UF Health Cancer Center, has helped oversee clinical trials in its UF Clinical Trials Office. The clinical trials office oversees trials conducted by UF researchers, and also supports UF principal investigators in getting their research to a clinical trial phase.

“We’re ensuring that we’re meeting the rigorous standards that protect patient safety, but also contributing to the knowledge of cancer care,” Wingard said.

With each of the 130 trials currently ongoing within the clinical trials office and 20 trials within the Pediatric Oncology Clinical Trials Office, UF clinicians and researchers are hoping to do just that.

Dang “Many times, it’s the only time the patient might get a drug that is the only drug that can help him or her,” Dang said. “In my 25 years of experience working in clinical trials, I have seen this multiple times: a patient’s only shot at life, at living longer, is if they get that drug.”

Clinical trials are research studies in which physicians test a drug that has not been used before — or test a previously used drug in a new way. Depending on the type of clinical trial, patients can receive the drug by itself or in combination with established drugs, said Nam Dang, M.D., Ph.D., director of the clinical trials office. Other trials require patients to not have been treated previously. And some clinical trials are offered to patients whose traditional therapy has failed.

According to a 2014 study published in the Journal of the National Cancer Institute, patients who participated in clinical trials had a better survival rate than patients who didn’t.

“Many times, it’s the only time the patient might get a drug that is the only drug that can help him or her,” Dang said. “In my 25 years of experience working in clinical trials, I have seen this multiple times: a patient’s only shot at life, at living longer, is if they get that drug.”

CLINICAL RESEARCH RIGHT AT HOME

Wingard is also working to support UF investigators.

“As a research university, UF is trying to contribute new knowledge and improve on cancer treatment outcomes — to not just perform the status quo, but recognize we need to improve it,” Wingard said. “It’s important we allow discoveries in the lab either at UF or elsewhere, and to put those in the hands of practicing clinicians,”

One of these investigators is Christopher Cogle, M.D., an associate professor of medicine. Cogle’s current research involves finding leukemia cells hiding within patients’ bodies. These cancer cells survive initial doses of chemotherapy by hunkering down in blood vessels. After the chemotherapy coast is clear, the leukemia cells can reemerge, putting the patient into relapse.

One of the aims of Cogle’s study is to use a drug to attack the safety sites that the leukemia cells create for themselves, said Joe Stokes, R.N., nurse manager of the clinical trials office’s malignant hematology division.

Stokes“Cancer treatment is moving to look at target therapies that really get to the root of the cancer and eradicate it by not allowing it to replicate rather than just killing everything and hoping it doesn’t come back,” Stokes said.

Brian Sevier, Ph.D., associate director of the clinical trials office, says it’s the role of physicians and researchers to explore these new therapies.

“Cogle had an original idea, and he’s gone and put that into practice,” Sevier said.

GIVING BIG ATTENTION TO SMALL PATIENTS

Alongside the UF Clinical Trials Office is the Pediatric Oncology Clinical Trials Office in the UF College of Medicine. The pediatrics office operates separately because the biology of cancers that affect children is so different from cancers that adults have, said Giselle Moore-Higgs, A.R.N.P., Ph.D., assistant director of the office.

The pediatrics office is affiliated with a national organization called the Children’s Oncology Group, a National Cancer Institute-designated research program. Being a part of that organization allows UF Health to tap into a network of children’s cancer research.

“Because most children’s cancers are rare, being affiliated with the Children’s Oncology Group allows you to focus your attention in a particular direction for the management of a particular cancer,” Moore-Higgs said. “That way, you don’t have lots of sites with multiple trials open, but only accruing one patient every five years. Instead, you have 150 sites accruing patients to a particular trial that many people think is the right direction to go.”

The 150 sites are spread across the United States and Canada.

Moore-Higgs also focuses on helping UF investigators apply for grants and get their own clinical trials established.

“If we didn’t have a clinical trials office, we wouldn’t have clinical research,” she said. “There are too many things that have to be done that physicians cannot do without having a clinical trials staff to do it — the data collection, the data management, the UF Internal Review Board management and regulatory support all has to be there.”

 EXTENDING OUR REACH

Drawing on a broad range of clinical research is partly why UF is developing its network further than just the Gainesville area. The UF Health Cancer Center announced its partnership with Orlando Health in December 2013, and has already begun collaborating with physicians there to enroll patients in clinical trials.

Additionally, the clinical trials office in Gainesville is an enrolling member for NRG Oncology, a nonprofit research organization within the National Cancer Institute. The organization conducts clinical cancer research and uses the study results to inform clinical research decisions and health care policy, said Alison Ivey, R.N., senior registered nurse supervisor for the clinical trials office.

Even when patients are ineligible for a clinical trial or choose to not enroll, their experience with UF Health can benefit them, Wingard said.

“We may find ourselves able to offer advice of additional treatment options to the practitioner in the patient’s local community,” Wingard said. “Other patients may choose to remain in UF Health to get their care. So it improves communication with our community oncologists, and also gives our patients more options, even if they’re not eligible to enter a trial.”

 THE REAL HEROES

In the UF Health Cancer Center, the clinical trials office revolves around the patient, Dang said. After all, it’s these patients who help researchers push the standard of care for cancer today, and create a new standard of care tomorrow.

“It’s an honor and a privilege to take care of this type of patient,” Dang said. “We make a huge effort to minimize risk when we conduct clinical trials. But there is a risk involved — a risk of the unknown. These patients hope the drug will work for them. Without them, there would be no new drugs, and no patients to be helped down the line. I tell my patients that in my mind, they are heroes.”

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Summer 2014

Paul Okunieff, M.D

From the Director’s Desk

Clinical trials are at the heart of every advancement in treating cancer, yet lack of understanding about the benefits, risks and opportunities that trials offer can sometimes prevent patients from taking advantage of the newest drugs and treatments they make available.

To Kill a Tumor

Researchers in the UF Health Precision Cancer Care Program are identifying the genes of lung and colon cancer tumors, forming the first center in the state to perform this testing for solid tumors. By identifying particular gene mutations that drive cancers, physicians can deliver better, more targeted treatments to those cancers.

The Great Unknown

Each year, more than 1,000 patients take part in clinical trials at the UF Health Cancer Center. All are helping UF researchers chip away at the great unknown: what makes each person’s cancer tick, and how to stop that ticking without causing harm to the patient over the course of treatment.

Clear As A Bell

UF Health cancer patients and their treatment teams rang the Liminal Bell, an art installation consisting of a bell created from an oxygen tank that is suspended from an oak beam structure. The word liminal is derived from the Latin word “limen,” which means “threshold.”

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