Clinical Trials Offer Possibility, Hope to Cancer Patients
Photography provided by UC Health
The University of Cincinnati’s Phase I Experimental Therapeutics Program – unique to the Tri-State region – continues to offer hope to cancer patients.
“Phase I clinical trials are important for patients who don’t have many standard treatment options because they involve therapies not yet available to patients off trial,” explains Dr. Trisha Wise-Draper, MD, PhD, medical director of the University of Cincinnati Cancer Institute’s Clinical Trials Office, a UC Health oncologist, and assistant professor in the Division of Hematology Oncology at the UC College of Medicine. “Although they are not promised to work, they give hope to patients left with no other treatment options, and are often of great benefit.”
As the name indicates, Phase I trials are the first research studies involving humans, evaluating how and how often a new drug should be given, and what constitutes a safe dosage. These initial trials typically include fewer than 50 people.
“To get drugs approved, you must do clinical trials. You can’t get to registration trials if you don’t have a Phase I program,” Dr. Wise-Draper continues. “Phase I is the first step. We have a fully dedicated Phase I program; what that means is we have investigators as well as mid-levels, nurse practitioners, dedicated to Phase I. We have dedicated Phase I hematology/oncology fellows who are able to screen and assess patients, clinical coordinators, a data manager and a dedicated Phase I pharmacist. We also have dedicated Phase I infusion nurses and dedicated clinics, which means we can do complicated assessments.”
Because the UC Cancer Institute is the only facility in the Tri-State offering a fully dedicated Phase I program, she adds, they offer a higher level of care than other centers.
“We have a very active Phase I program,” says program director Dr. John Morris, MD, UC Health medical oncologist, a professor in the Division of Hematology Oncology at the UC College of Medicine, and a member of the Cincinnati Cancer Consortium. The program was founded in 2008.
Example: In July 2016, Bexion Pharmaceuticals, located in Covington, received a “study may proceed” letter from the Food and Drug Administration regarding compound BXQ-350 – now in Phase I trials at UC – involving patients with solid tumors and glioblastoma, the most aggressive brain cancer.
“In the last few years, we’ve had a substantial number of trials involving new and novel cancer agents open, and some of the drugs we have tested here have turned out to be ‘winners,’ ” says Dr. Morris. “Take, for example, the immune-oncology drugs you see currently advertised on television. Those drugs have been a game changer for certain types of advanced cancer.”
He points to recent national data regarding patients participating in early stage lung cancer trials involving the immuno-oncology agents.
“The survival of these patients starting out was about 2 to 4 percent,” says Dr. Morris. “Looking at these drug trials, at the five-year point, about 16 to 20 percent of the patients are still alive. That is a remarkable improvement.”
Even completed Phase I studies lacking favorable outcomes are not without merit. Negative knowledge prevents researchers from “turning the same wheel again,” Dr. Morris says. It is only through discovery of innovative therapies through clinical trials, like those offered at UC, that researchers advance the battle against cancer.
A drug used in a Phase I trial has already been shown to be safe for animals. Dose escalation – where doctors slowly increase the administered amount of the drug under study per group of participants – helps determine what dosage works best without causing unacceptable side effects. Phase I trials also provide insight into how the human body absorbs and uses a drug. Although these studies are not designed to test how well a treatment or combination of treatments work, UC Cancer Institute officials note, the therapies administered during Phase I may help slow or stop the growth of a participant’s cancer.
Following Phase I, Phase II trials, which usually focus on a particular disease, continue to test the safety of a drug and begin to evaluate a drug’s efficacy, or how well the drug works. During Phase III trials, a drug, or combination of drugs, is given to large groups of people to confirm its effectiveness and compare it to commonly used treatments. After a drug is FDA approved and marketed, it can enter Phase IV in which rare side effects may be discovered not initially identified during testing. These trials are often carried out for a longer time and can involve thousands of participants.
Why participate in a clinical trial?
Through voluntary participation in Phase I clinical trials, people not only play an active role in their healthcare, they help advance medical knowledge and potentially help others, Drs. Morris and Wise-Draper conclude. Other advantages include access to new research treatments before they are widely available, and participants receive expert medical care from top university research physicians.
For more information about the University of Cincinnati Cancer Institute and UC’s Phase I Experimental Therapeutics Program, call 513.475.8000 or visit www.uchealth.com/cancer.