University Cancer & Blood Center (UCBC) opened a new 120,000 sq. ft. Comprehensive Cancer Center in August. Amidst all the latest, high-tech equipment, a wall-size whiteboard full of a handwritten list of clinical trials caught the attention of those touring the building. The list speaks volumes about some of the most important work that goes on in the new building.
100 active trials
What began over 20 years ago with Dr. Petros Nikolinakos and one research assistant has now grown into the second largest clinical research program in the state.
“Developing a new drug can take nine or more years,” Dr. Nikolinakos explains. “But with our research program, a clinical trial provides access years before drugs become available on the market.”
Every cancer therapy used today began as a clinical trial, which takes place in four phases. After laboratory and animal testing, Phase I determines human safety. Phase II compares doses to find what is most effective. Phase III tests the new therapy against the standard approved treatment. Phase IV answers additional questions and examines long-term effects. UCBC trials typically are in Phase III.
Questions
“There are a lot of fears and misconceptions around clinical trials,” says Mary Egan, clinical research manager. Concerns can range from skepticism of being a guinea pig to misuse of patient data.
Another common misconception is that a trial is a last resort. Egan clarifies that a trial can be an option as an initial treatment or as a change in a treatment.
“It can be considered at any point throughout the cancer journey – not just when all the stand of care options has been used and the patient is not responding.”
Many cancer clinical trials are evaluating the standard of care plus a new drug, Egan explains. The patient will always receive at least the standard of care treatment which may be combined with an investigational drug. Depending on when a trial is opened at a site, it is possible that a number of patients have already received the investigational treatment in earlier phases of the study.
She adds that there are multiple levels of safety review and extensive education, so a patient understands exactly what’s happening.
Trials do require more procedures or additional visits, but Egan says patients like having the extra attention that the nurse researchers can provide. Emotional and nutritional support has also been expanded in the new center.
She estimates that of 200 patients who visit UCBC in a day, only 3 to 4 are in a trial. There’s an intensive screening process that involves type of cancer, stage of the cancer and the blood markers. Biomarkers are objective medical signs (as opposed to symptoms reported by the patient) used to measure the presence or progress of disease, or the effects of treatment.
Clinical trials at the facility open and close constantly, and, of course, not all treatments will go on to be approved and available. Still, she says, “The knowledge gained from a trial of a treatment that doesn’t get approved is important.”
The future of cancer care
Cancer care is moving into a new frontier. Historically many cancer trials involved chemotherapy and while it still may be the appropriate option in certain cases, it’s not selective and can also affect healthy cells, explains Nikolinakos.
He notes that genomic profiling is now standard practice and allows for further characterization of a patient’s cancer. This allows for personalized treatment options based on a patient’s individual tumor profile. In fact, UCBC practice now includes a precision medicine coordinator.
UCBC participated in one of the first immunotherapy trials available to community practices. Immunotherapy uses certain parts of a person’s immune system to fight disease. The study was for metastatic non-small cell lung cancer patients who had received multiple lines of therapy. Patients were first enrolled in 2014, and the drug later went on to be approved in 2015.
“We have patients treated on that trial who are still alive and well today, Nikolinakos says. “Prior to immunotherapies, this survival was unheard-of in those patients.”
He adds, “Immunotherapy has been a game changer. We had trials for those drugs years before they were on the market.”
“Due to the knowledge gleaned from clinical trials, we are hopeful to see cancer move from a terminal illness to being treated as a chronic disease.”
