OKLAHOMA CITY – Stephenson Cancer Center at OU Medicine is participating in two clinical trials sponsored by the National Cancer Institute that will investigate the health of patients with cancer who are infected with the COVID-19 virus.
Both trials were scheduled to begin enrolling patients in mid-May, said Robert Mannel, M.D., director of Stephenson Cancer Center. As a National Cancer Institute-Designated Cancer Center, Stephenson is particularly well-equipped to enroll patients and conduct clinical trials while providing them the highest standard of care.
“There have been a number of reports that people with cancer face an increased risk for severe complications if they contract COVID-19,” Mannel said. “However, these studies have been relatively small and limited for various reasons. The only way we’re going to know if a strategy works is by conducting thorough, well-designed and ethical trials.”
One trial being offered at Stephenson Cancer Center is for adults being treated for cancer who also become infected with COVID-19. The clinical trial will follow enrollees for two years and will gather extensive data about their health with cancer, COVID-19 and any other medical conditions, as well as regular blood tests and examinations. The trial will consider the type of cancer the patients have and the treatments they’re receiving for it, and the interplay of those factors with their outcomes regarding COVID-19.
The study will also investigate the effects of cancer and COVID-19 among populations who are particularly hard hit by the virus, including African-Americans, Hispanics and Native Americans, especially Navajo Indians, Mannel said.
“This will help us learn more about COVID-19 and ways to address current infections, but it also will give us a database that will help us understand vulnerable populations in the future if we experience another wave from this virus or if another pandemic arises,” he said.
The second NCI trial focuses on tocilizumab, a drug that cancer physicians have used for several years to treat patients whose immune systems have become over-activated, Mannel said. When the body is attacked by something, be it a virus, bacteria or cancer, its immune system releases a cytokine called interleukin-6, whose mission is to rid the body of the invader. However, too much interleukin-6 can be released, resulting in cytokine release syndrome, which damages the body. It’s a particular risk for cancer patients who are receiving a cellular immune therapy like CAR-T. Tocilizumab is prescribed to block the release of excessive amounts of interleukin-6.
Many patients with COVID-19 also appear to experience cytokine release syndrome in which their immune systems go into overdrive with interleukin-6 release, Mannel said. The new clinical trial will study the effects of tocilizumab in patients with cancer who are also infected with COVID-19 and are experiencing respiratory distress. It is a randomized phase 3 trial in which half of those enrolled will receive tocilizumab and half will not, he said.
“In this trial, we’re not looking at how patients are doing with their cancer, but how the drug may be affecting their breathing problems,” he said. “We’re looking at the outcome – how long are people on oxygen, do they get out of the ICU and off a ventilator?”
The tocilizumab clinical trial is for children (over age 2) and adults with cancer who are infected with COVID-19. It also will seek to enroll minority and underserved populations who are disproportionately affected by COVID-19 and cancer.
“We’re grateful to the NCI for establishing clinical trials that we hope will lead to effective therapies and allow us to take better care of our patients,” Mannel said. “We will offer these trials to our patients at Stephenson Cancer Center, but we’re also willing to work with oncologists throughout Oklahoma to register their patients on the trials.”