If the experimental cancer drugs these nine individuals took while participating in early-phase clinical trials turn into breakthrough treatments, we owe them each a huge debt of gratitude.
And if it turns out that those drugs don't advance the ongoing quest to stop cancer in its tracks, we still owe these people for that knowledge.
All of them volunteered for Phase 1 cancer clinical trials at University Hospitals Seidman Cancer Center. These studies are the first step in determining if drugs and other therapies are safe in humans.
When their respective cancers no longer responded to standard treatment, they agreed to take drugs not yet approved by the U.S. Food and Drug Administration except for use in a study.
For the past 10 months, The Plain Dealer followed these patients through their journey as study participants in seven different Phase 1 trials at UH.
Undaunted that he would wear the "first-ever" label for his Phase 1 clinical trial, Vince Petro, 60, of Ashtabula, made his decision quickly.
Faced with what to do following his November 2011 surgery to remove an aggressive brain tumor, oncologists hoped he would agree to try a new stem cell gene therapy first conceived at Case Western Reserve University.
UH physicians had been looking for a patient to enroll in that trial for most of 2011. For them, Petro personified the opportunity to see whether the gene therapy that had showed promise in mice and dogs -- allowing them to tolerate stronger doses of cancer-fighting drugs -- would do the same in humans.
Not all of the patients The Plain Dealer followed are still alive. Last October, Janet Whitney of Brecksville and John Soley of Massillon died within one day of each other.
Their families talked about how the lives of others might change because of their loved ones' willingness to volunteer.
"She was always thinking about other people," said Andrea Whitney, Janet Whitney's daughter. "I think there's a part of you, when someone you love is gone, you want to know all of the impacts they've had in the world."
"He didn't want anyone else to suffer through this," Jeannie Soley said of the pancreatic cancer he had lived with since 2008. "That's what it was all about."
We almost never get to know the names of people who take part in early-phase studies that are crucial to new drug development, studies that emerge on the heels of promising laboratory research that is years in the making.
By the time the FDA approves a drug for widespread marketing and clinical use, hundreds -- sometimes thousands -- of patients have taken it.
But the number of patients involved in Phase 1 studies is small. And they largely remain anonymous, as do many of the countless scientists working in research labs where drug development begins; the physicians who are instrumental in designing and conducting the studies; the oncologists and nurses and others who provide patient care; the people who produce the consent forms that make the studies understandable to patients; the data and lab managers who collect and interpret information from studies.
UH is the lead institution for early-phase drug development at Case Comprehensive Cancer Center, a collaboration that includes the Cleveland Clinic and is based at Case Western Reserve University.
Case Comprehensive is one of just 14 centers to receive a multiyear grant from the National Cancer Institute to support its Phase 1 program. It is also part of a relatively new drug pipeline: The NCI picked Case Comprehensive researchers to use NCI-developed drugs in early-phase trials they design and run. Case Comprehensive is one of seven centers in the country with that distinction.
Case Comprehensive is also part of a larger network of hospitals, pharmaceutical companies, private organizations and governmental agencies that pursue cutting-edge science that has the potential to be tested in Phase 1 trials and evolve into effective cancer-fighting agents.
Drug development is a long road. Because of people such as Carl Gehringer Jr., Barbara Malone, Margene Manning, Latanga Nash, Vince Petro, Georgine Riley, John Soley, Larry Tremaglio and Janet Whitney, part of that road continues to run through Cleveland.
No comments:
Post a Comment