For the last year, Kari Vantol has come to the Avera Cancer Institute once a week to receive an infusion as part of her participation in a Phase 1 clinical trial.
She was originally diagnosed with colorectal cancer 10 years ago.
“Did the radiation, surgery, and chemo at that time, did well for five years, and in 2019, five years later, we found that the cancer had metastasized into some lymph nodes in my back, so then we started chemo again, and the cancer responded well again, so we did chemo and radiation, went on maintenance therapy, and then in 2022 it started growing again,” said Avera patient, Kari Vantol.
That’s when she started looking at other options. That included enrolling in a Phase 1 clinical trial right here in Sioux Falls, only about an hour away from her home.
“I really wanted to try something new, and when this opportunity arose here in Sioux Falls there wasn’t much hesitation,” said Vantol.
“She was the first patient in the US to be able to enroll in this trial that had already been going in Australia and South Korea. She has been the longest one in the United States because she has continued to see response to treatment,” said Avera medical oncologist, Heidi McKean, MD.
Avera has been involved in clinical trials for several decades, including Phase 3, which typically have hundreds or thousands of patients enrolled.
“The Phase 3 clinical trials have a drug that has moved through the phases of proving it’s safe and effective,” said Dr. McKean. “Those were our initial trials that we were able to get involved in, and we did well enrolling on those trials and helped patients have opportunities that they wouldn’t have otherwise had.”
More recently, Avera has been able to offer Phase 1 clinical trials. Typically these clinical trials are offered at larger institutes, making the Avera Cancer Institute rare in this offering.
“Offering early phase clinical trials really means that we have to come together as a team, from the principal investigator, the physician overseeing the entire team, to a strong research staff that is dotting every ‘i’ crossing every ‘t,’ making sure we know that protocol backwards and forwards and making sure we are doing everything correctly from the time we offer a study and consent the patient, through every single day that we take care of them,” said Dr. McKean.
That means this is the first opportunity that involves humans taking the drug or therapy. It requires careful monitoring of patients for side effects as well as positive trends in a patient’s condition.
“For a lot of the early phase, Phase 1 or Phase 2 clinical trials, patients will often have had to have the standard of care chemotherapy treatments or immunotherapy treatments already done and their cancer has grown through that standard of care and so they are looking for a different opportunity,” said Dr. McKean. “We know that clinical trials are a necessary part of trying to prove that an exciting drug in the lab can be safe and effective in humans, and maybe even better than standard of care, and so that’s why we push to have clinical trials available here, because that’s how you actually improve care for patients.”
Dr. McKean says these treatments start out as Phase 1, then move onto Phases 2 and 3, before potentially becoming standard of care.
“Proving that it is safe, proving it works against the cancer, proving that it is as good or better than standard of care, that’s how these new and exciting drugs get approved by the FDA so that all of us cancer doctors around the country can use them, and so I want patients to know that by them participating in clinical trials, it really moves the field forward,” said Dr. McKean.
And it’s an option patients have close to home.
“Yes I have to travel here once a week, but really that’s nothing compared to living in Houston or traveling to Rochester,” said Vantol. “Dr. McKean, April, and her team have to become very knowledgeable, but all the nurses, the nurses in infusion and at the hospital who did not know what I was going to throw at them, the nurses in the lab, pharmacy, they all had to become educated and prepare for this.”
