Medical centers across the country have slowed or stopped the enrollment of new patients in mesothelioma clinical trials because of the all-consuming COVID-19 pandemic.
The pause in enrollment options could be critical for newly diagnosed patients with pleural mesothelioma, whose life expectancy is often just six to 12 months.
Clinical trials are research studies where patients can find cutting-edge treatments not yet approved by the U.S. Food and Drug Administration.
Those experimental treatments go beyond standard of care, which generally has not been effective for this rare and aggressive cancer caused by asbestos exposure.
“The clinical trials are mostly on hold due to COVID-19,” Dr. Raphael Bueno, director of the International Mesothelioma Program at Brigham and Women’s Hospital in Boston, told The Mesothelioma Center at Asbestos.com. “[We] hope to open back up in May.”
The highly regarded Pacific Mesothelioma Center, which is part of the Pacific Heart, Lung & Blood Institute in Los Angeles, has continued screening patients for clinical trials, but on a limited basis.
Scientific advisor Dr. Robert Cameron, one of the country’s most respected mesothelioma experts, called clinical trial activity “day to day,” due to the pandemic.
The delay of clinical trials is one of many concerns facing patients with mesothelioma. Cancer patients undergoing treatment are typically immunocompromised and are at greater risk of serious health issues if they contract COVID-19.
Those already enrolled in a trial will continue treatment, but they must weigh the risks of being exposed to the virus at medical facilities. There is pressure on treatment centers amid the pandemic to ensure that in-person appointments are held only when absolutely necessary.
Most everyone in the country — including those who are healthy — continue to be under stay-at-home advisories to avoid spreading the potentially fatal virus.
“What happens with the lack of clinical trials is, treatment options lag behind,” renowned medical oncologist Dr. Bernardo Goulart of the Seattle Cancer Care Alliance told Asbestos.com Monday. “Medical needs of patients with mesothelioma remain unmet.”
Goulart said his research team temporarily paused a clinical trial involving T-cell therapy that included mesothelioma patients “due to the coronavirus pandemic.”
He said another mesothelioma clinical trial he had expected to open soon will be delayed “several months to even possibly a year from opening in part due to the pandemic.”
Medical facilities across the country are suspending clinical trials because they are overwhelmed by COVID-19 patients and much-needed resources are required elsewhere.
“This [pandemic] clearly is affecting our ability to accrue into all clinical trials,” Dr. Daniel Sterman, director of the pulmonary oncology program at New York University’s Robert I. Grossman School of Medicine, told The Mesothelioma Center at Asbestos.com Tuesday. “At high-volume COVID-19 clinical centers, such as ours, nearly all clinical and clinical research activity is being devoted to the pandemic.”
Sterman is a principal investigator of a phase III clinical trial for mesothelioma studying a much-anticipated three-drug combination of gene therapy, anti-inflammatory medicine and chemotherapy.
“Enrollment in clinical trials is challenging during telephonic or video visits,” said Sterman, who has been part of the pioneering efforts to improve treatment for mesothelioma for almost two decades.
Most of the clinical trials being conducted today are at least partially funded by the U.S. National Institutes of Health, which pumps billions of dollars into medical research.
Some facilities have continued to enroll patients in mesothelioma clinical trials, including a phase II study of a novel immunotherapy combination at Regions Hospital Cancer Care Center in St. Paul, Minnesota.
“We are not stopping during the coronavirus pandemic,” lead investigator Dr. Arkadiusz Dudek told The Mesothelioma Center at Asbestos.com. “Ten more patients are needed to close the study.”
A larger, multicenter phase II trial involving a combination of immunotherapy and cytotoxic therapy is still enrolling patients at a few of the sites, but not at most of them. One of those still enrolling is the Mayo Clinic in Rochester, Minnesota.
The COVID-19 virus has killed almost 13,000 people within the United States and more than 395,000 have tested positive for it to date. The search for proven treatments and vaccines continues to consume the medical community.