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Making Clinical Trials More Accessible

The University of Kansas Cancer Center is one of eight institutions in the country awarded an NCI grant to bring early-phase cancer clinical trials to patients in underserved and rural communities.

Illustration of an individual shivering in the rain as a physician runs toward them holding an umbrella. Physicians are holding umbrellas for other individuals.
Illustration by Dave Cutler

When Vincent Martinez was diagnosed with prostate cancer in 2003 at the age of 61, he wasn’t at all surprised. The Marine Corps veteran had long been anticipating the effects of Agent Orange from his two tours of duty in Vietnam.

Martinez first sought care at the Veterans Affairs (VA) Medical Center in Fayetteville, Arkansas, 75 miles from his home in Monett, a town of roughly 10,000 people in the southwest Missouri Ozarks. Urologists at the VA recommended radiation and surgery. Martinez instead decided to undergo a seed implant, which involves placing radioactive seeds into the prostate, at Mercy Hospital in Joplin, Missouri.

“The seed implant went well; my PSA levels dropped,” he said. (Prostate-specific antigens, or PSA, are an indicator of the disease.)

Martinez continued to do well for years. In 2016, his PSA began to rise slowly, and was being monitored by his urologist until it started to rise significantly in 2018. He sought care from an oncologist at the Freeman Cancer Institute in Joplin, who prescribed the testosterone-blocker bicalutamide (Casodex) until 2019, when the doctor then prescribed injections of the synthetic hormone leuprolide (Lupron). When those injections and oral hormonal therapy stopped working a couple of years later, Martinez was referred to Rahul Parikh, M.D., Ph.D., an associate professor of medicine at The University of Kansas Cancer Center.

Martinez first talked to Parikh via telehealth in November 2021.

“We talked about 45 minutes, and he gave me a lot of detail,” Martinez remembered. “Then we talked again after the first of the year, and I met with him at KU. That’s when he said, ‘You may be a good candidate for this [clinical] trial.’”

The current standard of care for patients such as Martinez is a radioactive drug called radium 223, which causes double-strand breaks in the DNA in tumor cells in order to destroy them. The clinical trial Parikh was recommending for Martinez, known as COMRADE (Combination Olaparib and Radium-223 in Men With Metastatic Castration-Resistant Prostate Cancer with Bone Metastases), combines the radium 223 with olaparib, a drug that inhibits that can repair that damaged DNA and thus keep the tumors from growing.

"Definitely there’s a disparity not just in good cancer care, but also in access to clinical trials. And studies have shown that outcomes are actually better in patients with cancer if they have access to those trials."

Today, Martinez is one of more than 20 patients with stage four metastatic prostate cancer who have enrolled in the COMRADE trial at the KU Cancer Center. He is also one of the 80 participants who have enrolled in such early-stage clinical trials at the cancer center since 2020, when the National Cancer Institute (NCI) awarded the center a $765,000 grant known as CATCH-UP (Create Access to Targeted Cancer Therapy for Underserved Populations).

Designed to address disparities in clinical trial participation that have existed for decades, CATCH-UP is a supplemental P30 support grant mandated by Congress to increase the enrollment of underserved people in early-phase clinical trials, such as COMRADE, that test targeted cancer therapies. These are therapies that bypass healthy cells and instead identify and attack genes and proteins that help cancer cells grow and spread.

The grant gives selected cancer centers access to a portfolio of potentially life-saving trials administered by the NCI’s Experimental Therapeutics Clinical Trials Network (ETCTN). It also requires that at least 50% of the participants enrolled in these trials come from minority and underserved populations. This includes people like Monett who live in rural areas.

“Traditionally on a study like this, 90 to 95% of patients would be from major cities, and the minority population and the underserved areas would not be well represented,” noted Parikh, who oversaw the COMRADE trial at the KU Cancer Center. 

Joaquina Baranda
Joaquina Baranda, M.D.

Joaquina Baranda, M.D., professor of medicine with a focus on gastrointestinal cancers at KU Medical Center and the site project leader on CATCH-UP, pointed to data released by the U.S. Food and Drug Administration (FDA) that revealed the enormous inequities in clinical trial participation in the United States.

“Everybody is talking about narrowing the disparities with race and ethnicity, and how people who are poor aren’t getting access to good quality cancer care,” she said. “But there is still such a small fraction of patients from minority groups who had access to about 37 drugs that were accessible only through clinical trials before they were FDA-approved. So, there is definitely a disparity not just in good cancer care, but also in access to clinical trials. And studies have shown that outcomes are actually better in patients with cancer if they have access to those trials.”

The Early Bird

Baranda, who also directs the early-phase clinical trials program at the KU Cancer Center, is quick to point out the value of early-stage trials in improving outcomes. In the old days, phase 1 trials tested for safety and side effects, and then only when that was finished did the researchers launch phase 2 to see if the drug was effective. Those days are long gone.

Thanks to advances in both the scientific understanding of cancer, of how new drugs work and in the design of trials themselves, many early-phase trials function as a combination of phases 1 and 2 and test for both safety and effectiveness if not at the same time, in rapid succession. A number of drugs have been given the green light by the FDA based on early-phase results, such as entrectinib (Rozlytrek), approved in 2019 to treat cancer patients with a particular genetic mutation that spurs tumor growth.

Moreover, with early-phase trials, there usually is no placebo group, so all participants in the trial receive the study treatments as planned, noted Parikh.

For patients whose disease has progressed on a variety of other treatments, gaining access to these new drugs and treatments is critical. But early-phase trials aren’t just for people who have run out of treatment options. For patients who have difficult cancers, such as pancreatic, for which the current standard of care is not very effective, “access to early-phase clinical-trial treatments is a standard of care,” said Baranda. “[But] the only way you can access these novel drugs are through early-phase trials because they are not available commercially. If you don't have access to those early trials, you're done.”

Unlike phase 3 trials that sometimes are accessible via a doctor’s office, early-phase trials are not offered at many cancer treatment centers because they are more complicated. They require closer monitoring for safety as well as pharmacokinetic studies, which are biopsies to determine what patients are most likely to respond to the new treatment. Meanwhile, underserved and rural populations tend to live far from major cancer centers, and clinical trials often require more frequent visits than standard care.

Leyla Shune, M.D., associate professor of medicine at KU Medical Center, enrolled patients into two novel immunotherapy trials via the CATCH-UP grant to treat people with relapsed refractory lymphoma. She said that rural patients can be hit with a double-whammy: They are especially vulnerable to lymphoma because of their exposure to fertilizer and other farm products, yet it is more difficult for them to access cutting-edge therapies.

“What is best for New York is best for Salina,” said Shune. “That is our thinking. Make it available to everybody who needs it. Everybody has a loved one, they have a family, they have their dreams and their hopes, and if we have an opportunity to cure them, they should be able to be offered the best drug available.”

Location, Location, Location

Reaching people outside of the walls of The University of Kansas Cancer Center, the only NCI-designated cancer center in the region, is the goal of the Masonic Cancer Alliance (MCA). As the cancer center’s outreach network, the MCA links the KU Cancer Center with regional hospitals and health providers throughout its catchment area — Kansas and western Missouri — to help ensure that everyone has the same access to care.

The NCI issued a request for proposals for the CATCH-UP grant in 2020,

Gary C. Doolittle
Gary C. Doolittle, M.D.

“It seemed like a natural for us,” said Gary C. Doolittle, M.D., medical director of the MCA who co-leads CATCH-UP with Baranda. “Dr. Baranda had built a strong phase 1 program, plus the grant was devised to reach underserved populations. Now that the NCI recognizes rural as ‘underserved’ it is so important to cancer patients in our region. We had an established rural clinical trials network that was ready for these new agents.”

The cancer center’s catchment center is 23% rural, according to Rural-Urban Continuum Code, a system developed by the U.S. Department of Agriculture that classifies counties on the basis of their population size and proximity to metropolitan areas. Many patients treated in Kansas City come  from a rural ZIP code. Moreover, nearly 90% of counties in the cancer center’s catchment area suffer from a shortage of primary care providers and are designated as Health Professional Shortage Areas by the U.S. Department of Health & Human Services.

When the KU Cancer Center was awarded the CATCH-UP grant in September of 2020, it became one of only eight cancer centers in the country to receive it, along with cancer centers at University of California Irvine Health; Wake Forest University Health Sciences; New York University Langone Health; Wayne State University; the University of Alabama at Birmingham; the University of Miami; and Dartmouth-Hitchcock Medical Center.

“We were in competition with all the other NCI-designated sites, and we were the only site at the time we applied that did not have NCI Comprehensive status,” said Doolittle.

(The University of Kansas Cancer Center became an NCI-designated Comprehensive Cancer Center in July 2022.)

Number One Site for Enrollment

If that meant the KU Cancer Center had something to prove, they proved it.

Through CATCH-UP, KU’s cancer center opened up 28 new early-phase clinical trials spanning a variety of cancers via the ETCTN, with many opening up in MCA organizations or community sites. During the first year, 47 participants were enrolled, nearly seven times the average annual enrollment in ETCTN trials at KU’s cancer center in previous years and more than any of the other seven cancer centers. And they enrolled participants quickly: The grant’s accrual requirement for the year was 24, and that criterion was met in just six months.

“The clinical trials office opened these trials in a matter of several weeks, which is just stunning — and this was during COVID,” Doolittle said. “We had more trials open in the first month than any of the other seven centers. If those trials were not opened in a timely way, if it was going to take four to six months to open them, we would not be the number one site in the country, by far, in terms of accrual.”

To spread the word about the new trials, Doolittle held Zoom meetings with physicians, nurses and research coordinators at MCA and community sites and sent email listings once a month about the specifics of all trials available.

The cancer center also used telehealth to screen some participants for trials. By screening Martinez first using an internet-based application, for example, Parikh made sure that Martinez did not make a three-hour drive to Kansas City for nothing.

“If there was a candidate for a trial who lived at a rural site, I could have a video call with them and give them some idea as to whether or not they were going to be a candidate, and then have them come down,” said Doolittle. “Using the technology in that way just makes perfect sense.”

"The Clinical Trials Office opened 28 new early-phase trials in a matter of several weeks, which is just stunning... If those trials were not opened in a timely way, We would not be the number one site in the country, by far, in terms of accrual."

Benefit for Everyone

To be sure, these trials were not offered only to underserved cancer patients. Anyone, regardless of socioeconomic or geographic status, who can benefit clinically from one of the clinical trials is eligible. But because of the populations the KU Cancer Center treats and the outreach done by the center and the MCA, more than 50% of patients accrued have been underserved.

The CATCH-UP grant was for one year, but the NCI has since awarded the KU Cancer Center an additional $192,000 because of its performance, particularly in exceeding accrual goals. The NCI has also granted the center formal membership in the ETCTN as part of the Yale Consortium. In addition to Yale and now the KU Cancer Center, this consortium includes Vanderbilt University, the University of Oklahoma, University of California at San Diego, Washington University in St. Louis, Columbia University and the University of Florida. As part of the ETCTN, investigators at the KU Cancer Center not only can continue to enroll any participant who stands to benefit from the early-phase trials the network offers, but it may also lead the development of clinical trials to discover better treatments for cancer patients like Vincent Martinez.

In the meantime, at the time of this writing, Martinez had just completed his fourth of six treatments under the COMRADE trial. He also had recently celebrated his 80th birthday, and was looking ahead to more.

“I’m going to keep the door open as long as I can,” he said.

Exploring Disparities in Health and Health Care

In this special issue of Kansas Medicine + Science, we are taking a closer look at the impact health disparities are having on the health of Americans.

The Rise of Citizen Journalism
A new collaboration is helping those who want to share the truth
about health care and other issues.

Making Clinical Trials More Accessible
The University of Kansas Cancer Center is one of eight institutions in the country awarded an NCI grant to bring early-phase cancer clinical trials to patients in underserved and rural communities.

The Crisis in Rural Health Care
The new Kansas Center for Rural Health is exploring ways
to reduce and eliminate health disparities in rural Kansas.

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