Tommy Stewart was already a prostate cancer survivor when, during his annual physical in 2004, his physician felt a nodule on his neck.
The first question people usually ask, he says, is whether he had any idea – a family history of thyroid cancer, maybe, or some physical indication of the cancer.
“But there’s no family history,” he says, “and the only thing I might’ve noticed was occasionally I had to clear my throat. Nothing out of the ordinary, though.”
An ultrasound revealed at least one mass but the biopsy came back inconclusive, so in early 2005, he was scheduled for a two-hour surgery that ended up stretching longer than eight. He had stage IV thyroid cancer that had spread to his vocal cords and the brachial plexus nerve in his shoulder.
Over the next four years he had multiple surgeries, several treatments, and many relapses – “they threw the book at me to get rid of the cancer,” he says, but nothing worked long-term. By 2009, he was just 64 and had run out of options.
In August 2009, however, he was referred to Antonio Jimeno, MD, a head and neck cancer and drug development specialist, and was considered for a phase I clinical trial being led by Wells Messersmith, MD; both are CU Cancer Center members and professors of medical oncology. The study was a dose-finding study for patients with advanced solid malignancies of an oral gamma-secretase inhibitor.
Though the trial wasn’t specifically targeting thyroid cancer, Stewart qualified for it and, after discussion and prayer with his wife, Sylvia, decided to join. His participation, as well as that of the thousands of people who participate in clinical trials with researchers in the CU Cancer Center every year, has helped to advance cancer treatment in significant ways, Jimeno says.
“Clinical trials have been the reason that survival and outcomes for major diseases such as breast, colorectal, thyroid, lung, ovarian, or head and neck cancers, among others, have significantly improved over the last 10 years," Jimeno says. "This is particularly true with the incorporation of immunotherapy and targeted therapies that not only prolong survival in many of the above settings but also do so with much fewer side effects than chemotherapy. We are truly witnessing a revolution, particularly involving those immune and cell therapies, and this all starts with a clinical trial."
Facing a second type of cancer
Stewart would need every bit of determination, resilience, and stamina he gained as a U.S. Army artilleryman – he retired a lieutenant colonel after 27 years of service – to face his unexpected cancer journey.
When he was diagnosed with prostate cancer in 2003, he experienced remission after receiving external beam radiation therapy. With his thyroid cancer diagnosis, Stewart received multiple surgeries, two significant radio iodine treatments, external beam radiation treatment, and an IR embolization procedure. Nothing was effective long-term. That’s when he learned about the phase I clinical trial.
“There are some instances where a cancer patient simply does not have any other option, there are no other therapies, doctors have given you all there is that’s known to work, and the options are to stop active therapy or try something new,” Jimeno, the co-Director of the early clinical trials group at the cancer center explains. “But as a researcher, I feel a profound responsibility, a need to be very careful and never sugar coat or try to over-emphasize the potential benefits of participating in a clinical trial.
“Sometimes, like in Mr Stewart’s case, the benefits in retrospect are staggering, but that’s not always the case. You want to be hopeful and positive, but also realistic and transparent, and especially you want to be honest about the investment in time and energy that a patient must make. Signing up for a clinical trial is a significant commitment, and some people value their quality of life and their remaining time and whether they want to spend it in a clinic, and there are several aspects to consider,” Jimeno says.
“In addition to the time investment, receiving a new drug that has not yet approved by regulatory authorities because it is still in development can be quite stressful, which is why I consider my patients by far the bravest people I’ve met. Lastly, participating in a clinical trial demands enormous amounts of patience. It takes a lot of courage and a lot of motivation.”
Stewart says he’s only half-joking when he explains that he and Sylvia looked at the clinical trial’s list of potential side effects “and my criteria was where is death on that list?” he recalls with a laugh.
“It takes a lot of courage”
It was the first clinical trial in which Stewart participated, and he was the second person to enroll in the phase I study. He took two pills a day and experienced no side effects, he says. The investigational drug, a gamma secretase inhibitor, was designed to target a key pathway altered in many cancers that some investigators have linked to cancer stem cells.
After six months, the cancer was clinically unidentifiable, though he remained on the trial until 2011, when he had to leave it after a scan revealed lesions on his mediastinum, a main compartment in the thoracic cavity. Though the lesions did not end up being a significant issue, “it was scary to come off the trial,” Stewart says. “It’s a very aggressive cancer and before all this, what did I know about cancer? My first thought with the prostate cancer was, ‘I’m going to die’.”
However, the thyroid cancer has not returned after 10 years off the drug, and Stewart, through his volunteer work with the Cancer Center Patient and Family Advisory Council and the Cancer Center Patient Education Committee, as well as other organizations, has become an advocate for clinical trial participation.
Participating in the science
The CU Anschutz Medical Campus is home to one of the largest clinical trial groups in the country, Jimeno says, “so it’s important for people to understand the fact that if one study does not work – either they don’t qualify or the treatment itself doesn’t benefit them – it doesn’t mean they do not have another option."
“Some patients find their right trial on their third, fourth, or fifth attempt. So, that combination of courage, patience, and motivation with that little sprinkle of resilience makes some folks actually benefit from the very deep and wide portfolio of clinical trials that we have for cancer and many other non-cancer areas at this university,” Jimeno says.
For Stewart, participating in a clinical trial not only provided him with a treatment option he hadn’t tried before, but allowed him to be a vital participant in the science that could benefit those who come after him.
“I tell people that you’re not just doing it for yourself,” he says. “You’re helping some of the best scientists, the best researchers in the world develop treatments that are going to benefit a lot of people down the road. And it’s not just a last resort, it’s not just for when you’re out of options. There’s research happening for whatever stage you’re at.”