Avera Cancer Institute in Sioux Falls, South Dakota, is now offering Phase 1 clinical trials for cancer patients, providing an alternative for those who have not seen improvement with standard treatments like chemotherapy or radiation. This initiative expands access to novel therapies and requires a dedicated team to ensure patient safety and accurate data collection.
Kari Vantol, a patient at Avera, has been participating in a Phase 1 clinical trial for metastatic colorectal cancer for the past year. Diagnosed 10 years ago, Vantol underwent radiation, surgery, and chemotherapy, experiencing remission for five years. However, in 2019, the cancer metastasized, leading to further treatments. When the cancer began growing again in 2022, she sought other options and enrolled in the Phase 1 trial.
"I really wanted to try something new, and when this opportunity arose here in Sioux Falls there wasn’t much hesitation," Vantol said.
According to oncologist Heidi McKean, MD, Vantol was the first patient in the U.S. to enroll in this particular trial, which had already been ongoing in Australia and South Korea. "She has been the longest one in the United States because she has continued to see response to treatment," Dr. McKean noted.
Expanding Clinical Trial Offerings
Avera has a long history of participating in clinical trials, including Phase 3 trials involving hundreds or thousands of patients. These later-stage trials assess the efficacy and safety of drugs that have already shown promise.
"The Phase 3 clinical trials have a drug that has moved through the phases of we can prove that it’s safe, we can prove it’s 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 otherwise have."
The addition of Phase 1 trials marks a significant step for Avera, as these trials are typically offered at larger institutions. Phase 1 trials involve the first administration of a drug or therapy to humans, requiring careful monitoring for side effects and potential positive trends.
The Importance of Phase 1 Trials
Dr. McKean emphasized the rigorous requirements for offering early-phase clinical trials. "Offering early phase clinical trials really means that we have to come together as a team, from the principle investigator, the physician overseeing the entire team. We have to have 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," she explained.
For many patients in Phase 1 or Phase 2 trials, standard-of-care treatments like chemotherapy or immunotherapy have already failed. These trials offer a chance to explore new avenues.
"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 stated.
Paving the Way for Future Treatments
Dr. McKean explained that treatments progress from Phase 1 to Phases 2 and 3 before potentially becoming standard of care. The goal is to demonstrate safety, efficacy, and superiority compared to existing treatments.
"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 really moves the field forward," said Dr. McKean.
Vantol appreciates the opportunity to participate in a trial 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," she said, highlighting the convenience and accessibility of Avera's clinical trial program.
