Kent Haffer remembers when his oncologist approached him with an unusual idea. It was 2013, and Haffer, a 55-year-old computer programmer living in St. Peters, Missouri, had been receiving treatment for advanced melanoma for eight years. His oncologist proposed that Haffer be part of a clinical trial, but not one involving hundreds of people. Instead, this study would have only one person in it: Haffer.
A one-person study is often called an N-of-1 trial (the N stands for “number”). Cancer researchers are increasingly looking at this investigational strategy to capitalize on the molecular information provided by genomic sequencing, in which cancer cell mutations are identified by analyzing a patient’s tumor. The idea is that the patient receives an experimental therapy targeted to those mutations and is monitored for disease progression and side effects while researchers collect data.
In Haffer’s case, that experimental therapy involved three doses of a cancer vaccine that he would receive every six weeks. His oncologist’s goal was twofold: One, he wanted the vaccine to help bolster Haffer’s immune system to prevent a recurrence of melanoma, which had been treated successfully in a traditional clinical trial. And two, he wanted to study Haffer’s response to the vaccine to see if it would be a valid approach in other patients.
Read more about N of 1 trials in my article from Cancer Today, here.
Image credit: Cancer Today