Cancer Patient Becomes First Person Ever to Receive New Drug
When Charlie Roser broke his leg, he quickly came to terms with the recovery process ahead. But a far more profound twist awaited the retired salesman in Clemmons, North Carolina.
At the hospital, he’d learn the largest bone in his body suddenly snapped because he has cancer. “When you’ve never been sick and all the sudden, you’re sick as hell, it’s a shock,” Roser said.
A lot’s happened since that whirlwind day on Nov. 8, 2020. Roser had surgery on his leg, got his diagnosis and endured months of chemotherapy and radiation. His cancer went into remission but quickly returned.
Thankfully, Roser had a “secret weapon” in Dr. Franklin Chen, a hematologist and principal investigator of multiple clinical research trials at Novant Health Cancer Institute – Forsyth.
Chen would propose a pioneering treatment plan, and Roser became the first person in the world to receive a new cancer drug in phase 1 clinical trials at the Donahue Developmental Therapeutics Unit in Winston-Salem.
“For years, patients had to travel far from home to seek out the newest treatments and clinical trials,” Chen said. “Now our patients have access to these trials close to home.”
‘You have cancer’
On what began as a typical Sunday in November 2020, Roser and his wife, Margaret, were watching the Dallas Cowboys play the Pittsburgh Steelers on the patio TV. As the evening cooled off, Margaret suggested they go inside at halftime.
“I tried to get up, but I was having trouble, so Margaret helped me up,” he said. “As soon as we reached the door, I went to take a step and heard a loud pop. I knew my leg was broken.”
A former volunteer firefighter and EMT, Roser expected to hear that he’d broken his leg. But doctors at Novant Health Forsyth Medical Center had other news to share.
“Someone came back in the room and said, ‘You have cancer,’” he said. Roser, 77, was stunned.
“They said, ‘The kind of break you’ve got here is what we’d normally see in a very bad car accident. Your femur, or thigh bone, is the largest and strongest bone in your body, and yours just poof, snapped above the knee.’ So, they knew there was an underlying reason.”
Non-Hodgkin’s lymphoma
After an analysis of his bone and a series of blood tests, Roser learned he has stage 4 non-Hodgkin’s lymphoma (NHL), a cancer that starts in the white blood cells, or lymphocytes, which are part of the body’s immune system.
About 70,000 new cases of NHL are diagnosed in the U.S. each year. It’s more common in men than women, according to the Centers for Disease Control and Prevention.
Roser has an aggressive type of NHL known as diffuse large B-cell lymphoma. It grows quickly in the lymph nodes and often spreads to other organs.
“In Mr. Roser’s case, the lymphoma likely started in his thyroid and attached itself to other areas, like his bone, as it spread,” Chen said. “Once his disease relapsed, however, I knew we’d need to explore treatment options outside of standard chemo.”
A team of cancer experts
Chen presented Roser’s case at a weekly meeting of cancer specialists. The hematology tumor board, which specializes in blood cancers, is one of about 25 tumor boards at Novant Health.
It is a multidisciplinary team of cancer experts, including up to five oncologists, who review and consult on patient cases. They determined Roser would be an ideal candidate for a new cancer drug, not yet studied in people, through a beginning clinical trial at Novant Health. Chen shared the news at their next visit.
“Dr. Chen said, ‘You know how I told you I had something in my back pocket if the chemo didn’t work?’” Roser said. “’Well, a clinical trial is starting, and you would be the first person to receive this particular drug. If it works, it could change the way cancer is treated forever.’”
“My wife and I just sort of looked at each other, and I said, ‘I’ll take the clinical trial,’” Roser said. “It was like a Ford Mustang had been lifted off my back.”
Early access to innovative treatments
Every drug approved for use in the U.S. is first tested by volunteers in carefully controlled clinical trials. This medical research makes innovative treatments available to people before they’re approved by federal regulators.
Clinical trials are conducted in phases that build on one another. “Each phase is designed to answer certain questions, so it can take years to see if a cancer treatment does what it’s meant to,” Chen said.
A phase 1 trial is the start of this research in people – only after pre-clinical findings (like cell or animal studies) suggest that it’s likely to be safe and effective. Roser had no reservations about participating.
“No matter what drug you’re taking … it was studied in a clinical trial before it ended up in your medicine cabinet. So, that’s the way I looked at it.”Charlie Roser.
A medical first
On Dec. 13, 2021, an IV delivered Roser’s first 90-minute infusion of the drug – a “fusion protein antibody,” which specifically targets lymphoma cells that have evaded the immune system.
The drug differs from chemotherapy in that it’s more targeted, said Dr. Alan Skarbnik, the principal investigator of this trial for Novant Health, and director of the lymphoma and chronic lymphocytic leukemia program, as well as experimental therapeutics in malignant hematology.
“Chemo is effective, but it’s tough on the body,” Skarbnik said. “It cannot distinguish between healthy cells and cancer cells, so it kills everything.”
Over time, scientists have finessed cancer treatments to target a specific cell or protein, expressed by the cancer cells while bypassing a person’s healthy cells.
“To be able to deliver this type of advanced care is, in many ways, delivering on the vision we had for the Novant Health Cancer Institute,” Skarbnik said.
World-class cancer care
Novant Health has two developmental therapeutic facilities – one in Charlotte and another in Winston-Salem – with the most advanced monitoring and drug infusion equipment available, as well as on-site lab support and research workstations.
“These clinical trials are extremely detail-oriented,” Chen said, “so running them perfectly is a necessity.”
Here’s why: Success or failure of a potentially lifesaving therapy hinges on proper administration of the drug in a phase 1 unit, Chen explained, along with precise collection of labs and other data.
“There are even clocks integrated into the electronic record system so pharmacokinetics, which are time-stamped lab draws, can be collected to a minute’s accuracy,” he said.
‘I’m a real happy camper’
Roser, who is still receiving weekly infusions at Donahue Developmental Therapeutics Unit, is about 3 months into the trial. Measuring its effectiveness will take time, but the new drug has shown promise.
“A PET scan revealed three of the five locations of cancer in my body were dissolved. Gone,” Roser said. “So, that means I’ve got two spots left that I’m dealing with right now.”
Aside from some coughing and his voice being strained, Roser hasn’t felt any of the extreme side effects that he experienced with chemotherapy. “No nausea, no loss of hair, no days of lost energy where I don’t want to get out of bed,” he said. “So, I’m a real happy camper.”
With side effects at a minimum and no hospital stays required, he has the flexibility to enjoy retirement with family.
“Margaret is my best friend. She’s my right arm,” he said adoringly of his wife. The two met as youngsters in rural New York and later moved south to further Roser’s lifelong career in sales. They have two daughters, he said proudly, and four grandchildren.
Just recently, they loaded up the car for a road trip to visit their daughter in Myrtle Beach, South Carolina. “And to celebrate St. Patrick’s Day,” Roser said, a nod to his heritage.
In the meantime, the phase 1 trial will continue at Novant Health and other carefully selected medical institutions around the country. By participating, Roser hopes for many years to come and, just maybe, to help others with cancer in the process.