A Volunteer for Life: Cancer Clinical Trials Close to Home
Chris Wolters is one of the faces behind Lake County’s clinical cancer trials
Any time you take a prescription drug or follow directions from your physician, you trust that the treatment is safe and effective.
That peace of mind is possible because of people like Chris Wolters of Mundelein. Wolters was diagnosed with a serious form of renal (kidney) cancer in 2008 and now volunteers in clinical trials, studies that determine the safety and efficacy of new treatments in humans.
Wolters’ positive attitude — and infectious cheerfulness — helped her to make the decision.
“You have to take what life throws at you, and I didn’t want to waste precious time,” she says. “The clinical trial gives me the chance to try a new treatment before it’s widely available and possibly help millions of other people, too.”
Clinical trials—here in Lake County
Until recently, the option of trying promising new treatments still in the testing phases was possible primarily at large, research-oriented university hospitals in or near Chicago. In fact, only three percent of cancer patients in the U.S. participate in clinical trials, mainly because of distance. That means some of the 800 potentially useful new treatments in trials nationwide may be delayed. Meanwhile, cancer continues to claim the lives of one in four Americans every year.
Wolters’ physician, Dr. Dean Tsarwhas, is a Northwestern Lake Forest Hospital oncologist who recently established clinical trials at his practice, in affiliation with Northwestern University, the Eastern Cooperative Oncology Group (ECOG) and Orchard Research. Now, in the Lake County area, a patient can participate in the same clinical trials found at academic research hospitals. (Currently there are 39 trials, for all types of cancer.)
Dr. Tsarwhas completed his fellowship training at the Dana-Farber Cancer Institute at Harvard Medical School, where he was immersed in an environment of research and clinical trials. He strongly believes they are a critical part of cutting-edge care.
“When patients would ask, ‘do you offer trials?,’ I could only help facilitate a trial downtown,” says Dr. Tsarwhas. “Now we’re making it available locally. Cancer patients already go to their local community hospital for 80 percent of their treatment.”
Out of left field
For Wolters, cancer showed up “out of left field.” In June of 2008, problems with a kidney stone brought her to the Emergency Room, and a mass was discovered on a CT scan.
Wolters’ kidney surgery eliminated the cancer and the stones, and she continued her same lifestyle without any symptoms. But a follow-up CT scan months later showed that the cancer had spread to her lungs and spine. Her physician referred her to Dr. Tsarwhas. After additional testing, Dr. Tsarwhas suggested that Wolters consider a clinical trial.
Like most people, she didn’t think much about clinical trials, even when research breakthroughs turned up in the news. But Wolters considered her options and embraced the opportunity.
“The arrangement was fabulous for me. If I had to travel far for the trial, I wouldn’t have been able to keep my job. I might not have participated.”
Saving lives with clinical trials
Any new approach to treatment first undergoes extensive studies on laboratory-grown cancer cells, as well as additional testing on animals such as mice. But mice and people are very different — and often more answers are needed.
Clinical trials for testing on humans are then divided into three phases:
- Analyzing effects on the human body and safe dosages
- Discovering its effect on the cancer
- Determining whether it’s better than the current standard treatment
“Clinical trials often involve testing new combinations of drugs or new ways of using them, rather than a completely new drug,” Dr. Tsarwhas explains. “In Chris Wolters’ case, we’re finding out whether an intra-venous biologic therapy that shrinks tumors in colon cancer will work for her kidney cancer.”
So far, Wolters, who also lost a sister to cancer, is thrilled with the results. The treatment is “keeping everything at bay;” her cancer hasn’t metastasized (spread) and she is still working full-time.
A wide safety net
Clinical trials do carry risks — there’s a chance the new treatment may be ineffective or worse than the standard. But strict safety protocols are built into every trial, and there’s reason to believe that the new treatment will be as good, if not better, than the standard.
The trials Dr. Tsarwhas offers to Northwestern Lake Forest Hospital patients and others follow Northwestern University’s Institutional Review Board (IRB) safety protocols. Patients are also enrolled in trials through an informed consent process to make sure they understand the procedures and risks.
Each patient is screened for eligibility for enrollment, using the clinical trial protocol. “This ensures adherence to the protocol guidelines, as well as patient safety during the screening process,” says Dr. Tsarwhas’ nurse practitioner, Jennifer Giarratana, R.N., M.S. “Patient safety is continuously monitored while the patient remains on the trial. We also collaborate with Northwestern University. Our practice has a great relationship with the oncology team there.”
Throughout Wolters’ 22 eight-week sessions, she’s closely monitored for any adverse events, and data is collected. Anything unusual or unsafe is graded and reported to the ECOG, where trial results are tallied. In some cases, trials have been discontinued or modified. Clinical trials are also voluntary, and patients can withdraw at any time.
“So many things helped me feel safe,” Wolters recalls. “The Northwestern University affiliation was part of it. Jennifer was wonderful about helping me understand my options and risks. And I know that I’m not married to this trial. The standard treatment is always available.”
The best of both worlds
Despite her battle with cancer, Wolters is determined to keep looking at the bright side of her situation.
“It’s actually kind of fun,” she says with a laugh. ”I’m part of medical history. I see my physician and nurse much more than a patient normally might, and my progress gets lots of attention. They have become like a second family to me. That’s important when you have cancer.”
For Dr. Tsarwhas, the clinical trials are a way to be involved with the kind of advanced care and research available at university institutions such as Northwestern Memorial Hospital and the Northwestern University Feinberg School of Medicine — while still allowing him the chance to provide more personal, community care.
“An important aspect of ‘cutting-edge care’ is simply having a team that returns phone calls and really enjoys taking care of patients,” says Dr. Tsarwhas. “Along with Northwestern Lake Forest Hospital and Northwestern University, we really are offering the best of both worlds here.”