Germaine Stivers’ journey with cancer has taken her to a place where no one has gone before.
The 62-year-old Lewistown woman, initially diagnosed with cervical cancer in 2013, is the first person chosen for a Phase 1 clinical trial that uses a combination of drugs to target HPV-infected cells and boost the immune system.
Since starting on the new regimen, Stivers has seen a turn-around in her life over her previous treatment.
“I don’t feel anywhere near like I did when I had chemo,” she said in a recent interview at the Billings Clinic Cancer Center. “The fact is I feel so much better. And I’m slowly coming back to being myself, maybe not physically, but emotionally.”
Stivers met for an interview with Dr. Justin Bottsford-Miller, Stivers’ gynecologic oncologist at the clinic, and Kelsey Skogen, clinical research nurse at Billings Clinic.
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Stivers, a retired elementary teacher and the mother of two adult daughters, remembered the exact date when she and husband Tom found out she had cancer: April 17, 2013. She had been experiencing a lot of pain, mainly in her abdomen and back.
Initially diagnosed in Lewistown with cervical cancer, which had spread to her lymph nodes, Stivers was referred to Billings Clinic for treatment. After a radical hysterectomy, chemotherapy and radiation, things seemed to be going well.
“Then I had a gall bladder attack and had to go in and have surgery,” she said.
That was in November 2014, when suspicious cells were discovered in the inner lining of her abdomen and a biopsy revealed the cancer had metastasized to her lungs as well. That’s when Bottsford-Miller joined the team treating Stivers’ cancer.
Since that time, Stivers and her husband have traveled to Billings Clinic once a month for chemotherapy.
“Mentally it wipes you out,” she said. “This was my new way of life.”
After each treatment she was tired and ill, and spent more than a week resting before she could think about getting back to her life.
Still, catching the cancer early was a huge break, Bottsford-Miller said. It let them get out in front of the cancer. But over time, the effectiveness of the treatment decreased, despite the fact that Stivers “had done an amazing job with it,” he said.
“We were needing a new direction,” Bottsford-Miller said. “And we had this clinical trial, and so we talked about it and decided to go forward with it.”
He learned about the trial from Dr. James Burke, a medical oncologist who used to work at the Billings Clinic and now works for Turnstone Biologics, manufacturer of the drugs that are part of the trial.
Patients had to meet a list of eligibility requirements to be considered for the new drug trial. Stivers “checked all the boxes” Bottsford-Miller said, diagnosed with recurrent cervical cancer driven by the human papillomavirus virus (HPV) and all her vital organs in good shape.
“So she qualified and went down that road,” he said. “She was the first person anywhere to get it.”
The Phase 1 study includes use of two experimental drugs that train the immune system to target HPV infected cells. Having done that, an immunotherapy drug, atezolizumab (trade name Tecentriq), is then used to turn up the volume on the immune system, to allow the body to attack infected cells.
The goal of the therapeutic clinical trial is to establish the appropriate dose and look at any side effects, Bottsford-Miller said.
“We do track whether someone is responding to it, but that is not the primary goal,” he said.
Skogen explained the trial began with one injection on the first day, called the primer dose, and then Stivers would be given two weeks to respond to it.
“She ended up staying in the hospital after the first dose until the second dose because she had flu-like symptoms,” including a high temperature, Skogen said.
Bottsford-Miller added that side effect “generated a lot of conversation” between him and those involved with the drug trial at Turnstone Biologics. The focus was on how the Food and Drug Administration would consider that side effect, in terms of patient safety.
Future injections occurred with no side effects, Stivers said.
“And I don’t feel anywhere near like I did when I had chemotherapy,” she said. “The fact is I feel so much better.”
Stivers is down to traveling to the cancer center once every three weeks for an infusion. Her visit includes drawing labs and checking her vitals, as well as watching for side effects, Skogen said.
Being the center of attention is a little embarrassing, Stivers said.
“You do feel like a specimen,” she said, smiling. “But this is something I should really be thankful for, and I am.”
Billings Clinic is one of five sites in the United States involved in this phase 1 clinical trial. The others include the University of Miami, Memorial Sloan Kettering Cancer Center, the Eleanor N. Dana Cancer Center at the University of Toledo and Anderson Cancer Center at the University of Texas.
Bottsford-Miller said he’s glad to be able to offer Stivers the treatment in Montana. Ten years ago, she would have had to travel to Denver or possibly Houston, he said.
“And not everyone has the ability to do that, never mind that the first two weeks require four infusions,” Bottsford-Miller said. “It’s nice we’re finally getting to the point we have the infrastructure to do that.”