Behind the Scenes: Finding New Options for Cancer Treatment

Patients of the Sandra & Malcolm Berman Cancer Institute appreciate the care they receive from everyone they meet. There are many, many more individuals behind the scenes equally invested in their care. 

One of those dedicated professionals is Steven Schmitt, BS, CCRP, the regulatory specialist in the Kahlert Foundation Research Center’s Clinical Trials Program. Steven, who joined GBMC 11 years ago, began as a research associate and now coordinates the clinical trials that benefit cancer patients. 

Working with Research Nurse Manager Laura Morse Cucci, PhD, BSN, RN, Steven helps to identify studies that will help GBMC patients. The team works with oncologists to choose which to join. Sometimes the oncologists learn of new drugs that might help their patients and request inclusion in the clinical trial. In other cases, the team looks for drug trials that align with the cancers oncologists are treating or are approached by those leading the studies. 

Once they find a clinical trial that will help patients, the process to open the study is complex “by design,” Steven explains. “Trials have to meet stringent ethical and scientific requirements.” It’s his job to ensure everything is done properly, culminating in the proposal presented to GBMC’s Institutional Review Board (IRB). 

There is a detailed checklist to complete, including a comprehensive review of the medical record to ensure that a patient being considered for a study will not suffer any predictable ill effects. Once the study is up and running – and there are about 40 open or running now – it is Steven’s job to manage the paperwork, contracts and budgets. 

Steven and his fellow researchers “follow patients along every moment,” he says. “In our department, there are 6 of us: 3 nurses and 3 non-nurse research coordinators. The nurses give the patients what they need, and we support them on the back end. 

“To me, it is equally rewarding even if we don’t see them face-to-face. We know exactly what’s going on with them.” 

Steven finds the work deeply satisfying. And sometimes it brings the chance to do something extraordinary. 

“Occasionally an opportunity will come up where a patient will have a very rare condition and you can work with a drug company to ask them to provide a drug for something that it wouldn’t normally be used for but there is some indication that it might work for this patient,” he explains. The company would provide the drug for a single-patient Investigational New Drug (IND) Study free of charge to find out if it can help a patient with the specific condition. 

Recently, GBMC’s Chief of Hematology, Dr. Zhuoyan Li, was treating a patient for a very rare inflammatory disease for which steroids were no longer effective. In fact, after years of successful treatment, steroid therapy had become detrimental to the patient’s health. The drug used in the IND study is used for many other conditions but had not been tested – and so had not been approved – for this disease, as it is too rare to support a standard trial. 

Steven continues, “We were able to get through one of these single-patient INDs and get this drug from the company to test Dr. Li using it to treat this patient. And he’s doing very well. “That’s really gratifying, when you can make the wheels turn for one particular patient and witness a positive impact in real time. We have the infrastructure to be able to make this happen.” 

Work isn’t the only source of happiness for Steven. He and his wife live in a farming community in Pennsylvania and have two young children, ages 3 and 1. As if that wasn’t enough to keep them busy, they have a vegetable garden during the season and are both musicians. As a new dad, it may be a while before he can get in enough clarinet practice to join the community band, but he is content to wait. 

In the meantime, he fills his kids’ bath time with music. “I'll choose an artist to play, just to expose them,” he says. “It'll be Coldplay one night and then U2 the next night and then Bruce Hornsby or Fleetwood Mac. I just want them to experience all kinds of music to see what they like.” 

His kids-first approach to parenting matches the patients-first attitude Steven Schmitt brings to GBMC. As he says, “There's an entire administrative world that goes mostly unseen that most people are not aware of.” That world is full of people devoted to giving our patients the care we would want for our own loved ones.