Clinical trials offer new lease on life for one patient
Steve Smith sits by the fire on the main floor of Providence guest housing. He’d flown in from Montana the night before and had just received his infusions. “I already had an expiration date,” he quips. It’s an amusing joke for the man who sold Proctor & Gamble grocery products for 29 years.
A frightening diagnosis
In February 2014, shortly after retiring and moving with his wife back to his boyhood home in Great Falls, Smith, 63, was diagnosed with stage IV colon cancer with liver metastases. He underwent chemotherapy for a year, a colectomy, seven tumor resections and removal of 24 lymph nodes. His cancer was stable for six months and then progressed.
With limited options in Montana, Smith and his oncologist began searching the Web and determined an immunotherapy trial offered the best hope. They found clinical trials that looked promising in Seattle, Phoenix and Minneapolis, among other cities, but decided on Portland, Ore., because of the pioneering work performed at Providence Cancer Center and for its proximity to Vancouver, Wash., where Smith lived for much of his career.
Screening period
In April 2015, Smith visited the cancer center to see if he qualified for the trial. The screening included urine testing, electrocardiogram, chest X-ray, tumor biopsy, CT scans of his chest, abdomen and pelvis, and brain and blood draws to verify the absence of complicating factors.
A screen for biomarkers, such as the nonmutated KRAS gene, suggested evidence to help investigators determine why Smith might respond to the drugs.
“Fortunately for me, I met the requirements. As a cancer patient, you have to investigate what’s out there or miss an opportunity,” he says.
Phase I/II study
Smith enrolled in a phase I/II dose-escalation and cohort expansion study. So far, he is one of nine people in his cohort who have received a mid-range dose of medication. By 2020, the target end-date of the trial, approximately 190 patients are expected to be enrolled at up to 15 sites in the country. This is the first time the drugs varlilumab and nivolumab have been tested together in humans.
The study also enrolls patients with other types of cancer, including:
- Advanced non-small cell lung cancer
- Metastatic melanoma
- Ovarian cancer
- Squamous cell carcinoma
- Head and neck cancer
- Colorectal cancer
- Glioblastoma
- Renal cell carcinoma
Excellent results
At the end of June 2015, two months after his screening visit, a CAT scan showed a 30-percent reduction in Smith’s tumors; by August, 43 percent; October, 60 percent; December, 75 percent; and at the end February 2016, when he received his last infusion of both drugs,
Smith’s tumors had reduced by 84 percent.
“I could be totally clear,” Smith says. “I’m not the only one who’s shaking his head.”
The long list of possible side effects is intimidating, but Smith shrugs off what he has experienced as mild – irritability at the site of his chest infusion port, joint pain and diarrhea. “You work it out when it’s all compared to staying alive,” he says.
Also, Smith’s quality of life has improved. He enjoys spending time with his family, which includes nine grandchildren and 12 great-grandchildren. And, he’s taken up a new hobby, panning for gold. “I’m healthy enough to enjoy retirement,” he says.