Dynamic duo in Pinehurst appreciates opportunity to participate in clinical trial

In Clinical Trials by Barbara Jacoby

From: sandhillssentinel.com

While FirstHealth of the Carolinas has earned widespread acclaim as a national leader in community health, Sandhills residents may not know of a superpower within the system that offers opportunities for patients in the region and worldwide: its extensive clinical trials program.

“FirstHealth offers a wide array of clinical trials that far exceeds the average for regional medical centers,” said Charles S. Kuzma, M.D., institutional principal investigator of clinical trials at FirstHealth of the Carolinas. “Patients who choose to participate in a research treatment opportunity at FirstHealth gain access to new, state-of-the-art treatments before they are widely available to the public. On a broader level, the advances in medicine we enjoy worldwide today are thanks in part to clinical trials as part of medical research.”

In January of 2012, removal of a melanoma from Ken Hill’s skin revealed an additional and different kind of cancer: chronic lymphocytic leukemia (CLL).

“When the melanoma was removed, the leukemia cells were attracted to the incision like little Pac-Men,” said Hill, a retired salesperson with Union Carbide and father of three. “I’m lucky I had the melanoma so the CLL was found.”

Between then and 2015, Hill did not undergo treatment for CLL, a type of cancer of the blood and bone marrow, because everything was stable. However, a scan in 2015 discovered otherwise; his blood was 80 to 90 percent saturated with cancerous cells.

To fight infection that could happen as a result of a weakened immune system brought on by the CLL, he started infusions of a blood product called intravenous immunoglobulin (IVIg) every 28 days.

His oncologist, Charles Kuzma, M.D., of the FirstHealth Outpatient Cancer Center in Pinehurst, told Hill and his wife Betty of a treatment clinical trial that he might want to consider adding to his IVIg infusions. The clinical trial’s purpose was to determine the efficacy of combining two drugs – a non-chemotherapy drug called ibrutinib taken orally each day and rituximab, a drug administered by infusion.

Ken and Betty determined this would be a good course of action and Ken started the trial. He took ibrutinib every day for a month. Then he added eight infusions of rituximab — one each week for four weeks and then one each month for four months. The rituximab was incorporated into his regular IVIg infusion regimen.

Eight months after the last rituximab infusion, a bone marrow scan showed that cancer cell saturation in his blood had reduced to 40 to 50 percent.

Now 27 months later his saturation level is 20 to 30 percent. He continues his daily dose of ibrutinib and infusions of IVIg every 28 days, and he will maintain this regimen until his condition changes or the end of the clinical trial in 2025.

“We don’t know the results of the clinical trial, but something is working for him,” says Betty, 80, of her 81-year-old husband.

“We feel blessed that this clinical trial was available in Pinehurst and that Ken was chosen for it,” said Betty, a dynamic partner in Ken’s health. The sponsor of the trial, Alliance for Clinical Trials in Oncology, funded the cost of the ibrutinib.

“When Dr. Kuzma recommended this clinical trial, Betty and I read all the research and I knew it would be good for me,” said Ken. “We’re now advocates for others to participate in a trial.”

He and Betty are training to serve on FirstHealth Cancer Services’ Cancer Advocacy Advisory Board, a peer support group sponsored by the Southeast Clinical Oncology Research Consortium.

“We want to be an encouragement for others,” said Betty.