Approximately one in three or four Americans will get skin cancer in their lifetime, according to Dr. James Borders, and less than 5 percent of those are melanoma cases. However, melanoma cases are responsible for about 70 percent of skin cancer deaths.
Under the leadership of Borders, a new study is underway at Central Kentucky Research Associates in Lexington to develop a vaccine to prevent so many melanoma tragedies.
“This vaccine is intended for people who have just had a melanoma surgical procedure, and the pathology report returned showing that it’s beyond the early stage,” said Borders, the study’s principal investigator and partner at Borders and Associates. “Most melanomas are found at a completely curable stage.”
The study is open to the general public and also is relying on referrals from doctors. In order to be eligible, patients must have specific qualifications in terms of the severity and depth of their melanoma.
“If a person had a pathology report that was worrisome but the surgeon said, ‘But we got it all, we have it all removed,’ there is no available medication to reduce the risk of returns,” Borders explained. “Preliminary research on this vaccine indicates about a 50 percent reduction of a rate of recurrence.”
Borders said the study’s sponsor, Polynoma, LLC, has already taken the vaccine through phase one of studies and they revealed the promising effects with minimal side effects. The study conducted by Central Kentucky Research Associates will take a couple of years, with patients receiving multiple treatments (more than 10 injections of the vaccine) and will give a more formal test of effectiveness and side effects. Meanwhile, participants will still be followed by their regular physicians and oncologists.
The vaccine, which Borders called cutting edge, is more of a prevention strategy rather than a treatment, which is the intent of some of the other medications currently on the market.
And while the study is rather small in scope compared to many of the other 15 to studies conducted per year at Central Kentucky Research Associates, director of marketing and patient recruitment Greta BonDurant said, “The melanoma study is particularly exciting because melanoma patients currently don’t have many options for treatment other than chemo, radiation and/or surgery.
“The vaccine that we’re evaluating looks very promising and could be a real breakthrough for those people,” she added.
Qualified participants for the study will be compensated $50 per clinic visit for their time and travel. Borders said Central Kentucky Research Associates is contracted to study approximately 10 to 12 patients and that admittance is competitive. Other doctors he works with are excited about the vaccine study, he said.
“Our plastic surgeons and oncologists who work with this are very excited about the prospect of this,” he said. “Everyone I’ve pitched the study to says, ‘I finally have something to offer these people.’”
Borders said that even the people who are participating in the study are getting something in return — a chance at wellness. He added that the vaccine is very expensive, as are most experimental vaccines at Central Kentucky Research Associates.
“So those who participate are getting potentially very valuable medication without cost,” he said.
Borders, a doctor of internal medicine, is Central Kentucky Research Associates’ principal investigator and oversees most of the contracted studies.
“Every sponsor deals with primarily contracted research centers,” he explained, adding that typically research sponsors approach research centers like CKRA with new studies like this one.
BonDurant said if a particular study requires a more specific doctor like an obstetrician or pediatrician, Central Kentucky Research Associates has a pool of doctors on hand to call to oversee the study.
Once the study is complete, all of the exhaustive information concluded from the research will be sent to the U.S. Food and Drug Administration, which then controls the release of the new vaccine to the marketplace.
“There are fast-track processes, and some of the cancer drugs do get quick approval,” Borders said. “But it may be a year.”
With rates of melanoma on the rise, Borders said, the vaccine is more crucial than ever.