Cancer Clinical Trials Tested, Continue During COVID-19 Pandemic

As a last-ditch effort to halt the head and neck cancer that had spread to Bernard Thurman’s lymph nodes and lungs, his doctors referred the 56-year-old Orange County resident to a clinical trial offered at Moores Cancer Center at UC San Diego Health. It was early March, just a week before California initiated a shelter-in-place ordinance.

“Initially, the trial I was going to undergo involved a surgical procedure and an ICU (intensive care unit) stay, but it was put on hold by all hospitals because they wanted to preserve ICU beds in case they were needed for patients with COVID-19,” said Thurman. “That changed my care plan. It was disheartening.”

Thurman was initially referred to a cell therapy trial led by Ezra Cohen, MD, associate director for translational science at Moores Cancer Center. When the trial was paused, Cohen conferred with colleagues and identified Duet 2, a Phase I clinical trial for select advanced solid tumors that did not require a hospital stay and had the potential to have a positive result on Thurman’s cancer. The trial uses a bispecific monoclonal antibody — an artificial protein that binds to two different types of antigen — to engage multiple T-cell targets simultaneously with the intent of making combination immunotherapies more effective.

“Cancer does not stop. It will grow without treatment. It is not an elective disease or procedure,” said Cohen. “It remains critical to continue to do research during this time. Especially for patients like Mr. Thurman who have exhausted treatment options. More than 1,600 people die of cancer each day in the United States. That’s not going to abate because of COVID-19.”

With 195 cancer therapeutic trials available at UC San Diego Health, ranging from experimental therapeutics to specific tumor types such as breast, blood and marrow transplant and lung, patients are guaranteed to receive the highest level of care available. Through these trials, patients may also benefit from the newest therapies offered only through clinical trials.

“To pause clinical trials during a pandemic would be a disservice to patients facing life-threatening diseases like cancer,” said Sandip Patel, MD, director of the Moores Cancer Center Clinical Trials Office. “The risk of COVID-19 is not subsiding and no patient with cancer can wait for a year — or potentially longer — for a vaccine before continuing their cancer therapy. Why not offer cancer treatment on clinical trials if we know we can do it safely?”

Catherine Circo, 32, was a month into a clinical trial for the treatment of cervical cancer when the novel coronavirus forced hospitals to re-evaluate which clinics would continue to see patients in person, which would need to move to telehealth and which would need to pause treatment altogether.

“My cancer was growing rapidly. From one scan to another, it grew one centimeter (approximately one-third of an inch). The idea of pausing was scary, but they decided that my treatment plan was essential so we continued,” said Circo. “When the pandemic hit, I wasn’t worried about contracting COVID because I saw that Moores Cancer Center took quick action. Patients and employees were wearing face masks and visitors restrictions were put in place. I had peace of mind knowing they were taking such strong action.”

Circo visited Moores Cancer Center five days a week for nearly two months while enrolled in the clinical trial NRG Oncology GY017, a Phase I trial investigating the optimal sequence of immunotherapy and chemoradiation. The trial also looks at the underlying immune mechanisms of response to therapy with radiation.

“The trial allows us to stimulate a patient’s own immune system while receiving chemotherapy and radiation,” said Jyoti Mayadev, MD, chief of Gynecologic Oncology Radiation Services at UC San Diego Health and principal investigator for the NRG Oncology trial. “This course of chemo-radiation has the potential to offer longstanding curative therapy. If a patient recurs after standard radiation, the disease is often incurable. The clinical trial represents a national effort to personalize treatment for cervical cancer.”

At the start of her treatment, Circo was so weak from radiation therapy that her father wheeled her to appointments. When the pandemic hit, visitor restrictions were added as an extra safeguard to protect patients, visitors and team members. Circo’s father could now only wheel her to the door. Her health care team would take it from there.

“You go into chemo thinking you’ll have someone there with you, but then you’re alone,” she said. “The staff and nurses were always supportive and had smiles on their faces — smiles you could even see through the masks. That made it easier.”

Thurman also observed the many changes made to keep him and others safe. Among them are monthly COVID-19 testing of patients receiving infusion services, more frequent cleaning, health screening of patients, visitors and staff as they arrive each day and a requirement that everyone wear masks. When his appointments did not require a physical presence, Thurman also benefited from telehealth visits, doing follow-up visits via video chat.

“Telehealth was very convenient, but when I have to go in person I know I am going to a cancer specific building with restrictions and safeguards making it safer than going to the grocery store,” said Thurman.

Unfortunately, enrollment in clinical trials slowed as California began to shelter-in-place and hospitals and clinics reduced in-person visits. In most cases, patients already enrolled in trials, like Circo, continued their treatment, but recruitment for new participants began to wane in March.

“Clinical trials depend on referrals, but if a gastroenterologist is unable to perform a colonoscopy or a biopsy, then we don’t know if a patient has cancer,” said Patel. “As in-person visits have increased, and patients feel safe seeing their doctors again, we are seeing enrollment in clinical trials pick up again.”

In April, trial enrollment hit its lowest point with a 50 percent drop in patient accrual. May and June enrollment increased, albeit with a 30 percent decrease compared to previous years. July data indicates a further uptick in enrollment, demonstrating the need patients have for cancer therapies at UC San Diego Health.

“UC San Diego Health stepped up and made sure I got the next best thing,” said Thurman. “It’s literally a matter of life or death for me. None of the treatments I have undergone so far have worked. This is one of my last remaining options.”

Search for available clinical trials for cancer, heart disease, mental health and more at clinicaltrials.ucsd.edu.

###

Original post https://alertarticles.info