Carl Paulk Defies Metastatic Melanoma

Carl Paulk
“I’m one of the lucky ones. I got a second chance at life,” Carl Paulk says.

 Defying Metastatic Melanoma: Tarpon Springs Roofing Contractor Thrives On Keytruda Trial

 By Michelle Bearden

 Carl Paulk is a dedicated ambassador for sun protection. He’s never outside without a wide-brimmed hat that covers his ears and neck, and SPF 70 sunblock on any exposed skin. He urges friends and strangers alike to get regular dermatology checkups. And he preaches about early detection at every chance he gets. If you see a small bump or mole, he says, get it checked – immediately.

 After his father died suddenly at age 51, Carl Paulk had to grow up very quickly. He was just 21, and his brother Lester, 23. The burden of taking over their father’s roofing business fell squarely on their shoulders.

 “We were proud of our dad. He was a World War II veteran, a decorated paratrooper,” Paulk says. “And his roofing company had such a good reputation. We wanted to keep it going in his honor.” He has never regretted that decision. But ultimately, working in a profession that kept him in Florida’s hot sun most days nearly led to Paulk’s death.

In 2006, the Tarpon Springs man, then 57, felt a lump behind his left ear. He attributed it to putting on and taking off his sunglasses several times a day. He wasn’t overly concerned about it but decided to make an appointment with his dermatologist. She took a biopsy on a Thursday, and the lump bled. The next day she called Paulk with the worst news possible: melanoma. She was able to schedule an appointment with him at Moffitt Cancer Center for Monday.

“You get news like this, and your whole world stops,” Paulk says. 

According to the National Cancer Institute, an estimated 76,100 Americans will be diagnosed with melanoma, and some 9,710 will die of the disease this year. 

Paulk’s wife of 28 years, Sharon, began reading everything she could about the disease on the Internet. That only made them feel worse. They learned melanoma is a skin cancer that begins in the cells that produce skin pigment, “the melanocytes.” These cells produce melanin to protect skin from the harmful ultraviolet rays of the sun. However, UV rays can damage the DNA, or genetic material in skin cells. The genetic damage can cause uncontrolled cell growth and cell division that can develop into melanoma. Unlike many other skin cancers, melanoma cells can spread quickly to vital organs. 

There was a ray of hope: If caught early, the disease is almost always curable. But if it gets just a little bit thicker, or if the cells break free and get into the lymph nodes, it can turn into a deadly and treatment-resistant disease. 

The couple met with Moffitt surgeon Gerard Mosiello, M.D., to discuss the upcoming surgical procedure. And, fortunately, the cancer had not spread to Paulk’s lymph nodes. After surgery Paulk went through an arduous schedule of daily radiation for a month. He then underwent a 30-day round of chemotherapy, followed by interferon three times a week for a year.

After periodic checkups, Paulk seemed to be responding well and was feeling optimistic that he would get an all-clear report. But it wasn’t to be. Instead, the doctor found that the cancer had spread to his neck. Tests revealed three tumors and the worst possible news: stage 4 melanoma.

Paulk enrolled in a clinical trial with an experimental drug, but after a few treatments, it became clear that was not an option. His liver enzymes had skyrocketed. His weight was dropping, and he was weak. But another option was available – this time a trial with pembrolizumab (Keytruda®), an anti-PD-1 inhibitor. Paulk felt this was his best chance at survival. PD-1 refers to a cellular pathway that restricts the body’s immune system from attacking melanoma cells.

In October 2012, he began a regimen that mandated visits to Moffitt for treatment every three weeks for an undetermined amount of time. The fact that Moffitt is one of the world leaders in early-phase and mid-phase trials in metastatic melanoma also meant Paulk was in the best possible place to battle his particular disease.

“I was willing to try anything,” Paulk says of his decision. “It was too early in the development stages to know if it would work, but I felt the alternatives weren’t too promising.” Almost immediately, his condition began to improve. Every 12 weeks, he underwent brain and body scans to monitor his progress. The tumors – one large and two small ones – began shrinking. Even better, he didn’t have side effects generally associated with some drugs.

The roofing company is still in operation, with Paulk at the helm and his middle daughter, Stephanie, working alongside him. He feels strong enough that he still climbs on roofs to get estimates, but he leaves the physical labor to his workers.

And more good news: In September 2014, two years after Paulk began the trial, the U.S. Food and Drug Administration approved the new cancer immunotherapy for treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs. The approval is a major milestone in the treatment of the disease. Though the trial is complete, Paulk continues to get the drug every three weeks. He will stick with the treatment indefinitely, so researchers can determine whether there are any long-term ramifications. Meanwhile, his tumors continue to get smaller.

“I’m one of the lucky ones. I got a second chance at life,” Paulk says. “For me, this was a miracle drug. And it’s going to save a lot of people in the same boat. I’m glad for my small role in getting it approved.”

Melanoma Drug Blocks PD-1 Cell Pathway

The FDA approval of Keytruda® (pembrolizumab) in September 2014 addressed a medical need for patients with advanced melanoma who were no longer responding to other drugs. Keytruda, marketed by Merck & Co., is the first approved drug that blocks a cellular pathway known as PD-1, which restricts the body’s immune system from attacking melanoma cells, according to a release by the FDA. Pembrolizumab is an effective drug that will prolong survival for many patients with metastatic melanoma.