African-American patient makes history; raises important discussion about minority participation in clinical trials

As the nation celebrates Black History Month in February, VCU Massey Cancer Center celebrates cancer patients who are making history. African-American Junius Hayes is one of them, helping medical researchers to pioneer new treatments for cancer.

Hayes was the first patient in the United States to participate in a clinical trial to test a biodegradable balloon that, when inflated, would allow for more targeted radiation treatment of prostate cancer with less damage to the healthy areas surrounding the prostate.

After being diagnosed with early-stage prostate cancer, Hayes was presented with the opportunity to participate in the BioProtect trial. The trial was led by Mitchell Anscher, M.D., Florence and Hyman Meyers Chair of Radiation Oncology and co-leader of the Radiation Biology and Oncology Program at VCU Massey Cancer Center, who was the first physician in the U.S. to test the Israeli-created product.

“When the medical team told me the science behind the trial, I had to chuckle. I knew all about the materials being used in it because I helped develop them for different applications,” said Hayes. Passionate about science and technology since he was young, Hayes nearly pursued a career in medical research, but ended up using his degrees in biology and chemistry with jobs at NASA and the Department of Energy. It was at NASA that Hayes helped develop the materials that years later were used for the BioProtect balloon.

Hayes agreed to participate in the trial, and it successfully treated his cancer.  After eight weeks of radiation, he received a clean bill of health.

“The clinical trial beat my cancer, and it also offered me a great opportunity to impact medical research,” said Hayes. “If I’m able to help advance science in any way, then I’m thrilled to have participated.”

Hayes’ participation in the clinical trial made history, but his inspiring story raises an important discussion about clinical trials in the minority community. Having had extensive knowledge in a scientific field, Hayes is a special case. As Massey researcher Lynne Penberthy, M.D., Ph.D., found, for a majority of people, the decision to participate in a clinical trial can be overwhelming.

Penberthy led a team of Massey researchers to study the reasons why Caucasian and African-American patients who are offered a clinical trial are ineligible or refuse to participate.

“Many studies have been done to retrospectively capture information on clinical trials, but this is the first study to prospectively find out the reasons for ineligibility or refusal at the time when the patient is offered the opportunity to participate,” she said.

Penberthy’s team discovered that Caucasian patients are more likely to be ineligible to participate due to their type of cancer or characteristics specific to the study. But African-American patients were more likely to be ineligible because they were unable to provide informed consent or had challenges with compliance, such as the inability to attend appointments due to lack of transportation.

As for reasons for refusal, Caucasian patients were more likely to refuse due to the extra burden related to traveling to the additional clinic visits that clinical trials often require; preference for their own physician versus the physician leading the trial; or concerns about randomization or toxicity. African Americans were more likely to refuse due to lack of interest in a clinical trial, family pressures or feeling overwhelmed by their diagnosis.

“It is important for clinical trials to have participants from all different ages, races, sexes and ethnicities, so that the results can have a much wider applicability and, therefore, medical advancements can help more patients,” said Penberthy. “But unfortunately, there continues to be a huge gap between Caucasian and minority participants despite the National Institutes of Health’s 20 years of focus on increasing minority participation.”

According to the Center for Information & Study on Clinical Research Participation, of the 75,215 patients who enrolled in National Cancer Institute-sponsored clinical trials from 1996 to 2002, 85.6 percent were Caucasian, 9.2 percent were African American, 3.1 percent were Hispanic, 1.9 percent were Asian/Pacific Islanders and 0.3 percent were American Indians/Alaskan Natives.

Penberthy hopes her research will inform cancer centers of patient barriers so that they can close the accrual gap in minorities by addressing the barriers specific to their minority patients. To help improve the clinical trial process, she suggests that cancer centers select clinical trials that are most appropriate for their population and change the eligibility criteria that restrict the participation of minority patients.

“Our next step is to continue analyzing and gathering data that could support further studies that address minority accrual barriers. Once we better understand the barriers, we can address them, and hopefully have more outcomes like that of Junius,” said Penberthy.

Hayes’ contribution to the advancement of cancer treatment is profound. Because of Hayes’ participation in the clinical trial, and the participation of many other patients like him, the BioProtect balloon is now beginning to be implemented worldwide for the treatment of prostate cancer. Hayes’ contributions also extend beyond cancer research. He made history at the Department of Energy, where he worked to create the Office of Minority Impact, increasing minority participation in energy programs.

VCU Massey Cancer Center is designated by the National Cancer Institute as a Minority-based Clinical Oncology Program for its dedication to reducing cancer incidence and mortality rates among minorities. Providing one of the largest offerings of clinical trials in Virginia, VCU Massey Cancer Center is continually evaluating the latest cancer therapies, with more than 150 studies on more than 20 types of cancer from brain and breast, to leukemia, prostate and more.

Penberthy collaborated on this study with the following researchers from the Virginia Commonwealth University School of Medicine: Richard Brown, Ph.D., chair of the PRMC Cancer Prevention and Control Subcommittee at VCU Massey Cancer Center, Department of Social and Behavioral Health; Maureen Wilson-Genderson, Ph.D., Department of Social and Behavioral Health; Bassam Dahman, M.S., Ph.D., Department of Healthcare Policy and Research; Gordon D. Ginder, M.D., director of VCU Massey Cancer Center, Division of Hematology, Oncology and Palliative Care in the Department of Internal Medicine; and Laura Siminoff, Ph.D., associate director for Cancer Prevention and Control and Theresa A. Thomas Memorial Foundation Chair in Cancer Prevention and Control at VCU Massey Cancer Center and chair of the Department of Social and Behavioral Health.

This study was supported by National Cancer Institutes of Health-National Cancer Institute Cancer Center Support Grant P30 CA016059.

The full manuscript of Penberthy’s research is available online at http://ctj.sagepub.com/content/9/6/788.long. For more information about clinical trials at VCU Massey Cancer Center, visit http://www.massey.vcu.edu/clinical-trials.html.