Bold steps toward a cure: Clinical trials at City of Hope

May 3, 2019 | by Abe Rosenberg

Saul Priceman in Research Lab Researcher Saul Priceman, Ph.D., prepares cells for a CAR T cell therapy clinical trial
Nathan Dotson was worried.
 
A routine physical exam in 2014 revealed a high PSA level, suggesting possible prostate cancer. A few scans and biopsies later, Dotson got the bad news.
 
His cancer was advanced. It had spread to his bones and the outlook was grim.
 
No traditional cancer-fighting treatment would do him much good. There is no cure for advanced metastatic prostate cancer. Some drugs may temporarily slow the cancer’s growth and spread, but prostate cancer cells eventually adapt, rendering even those treatments ineffective.
 
“I was down and depressed,” Dotson remembered. He contacted several institutions, looking for a second opinion, hoping for a better outcome. “Everyone said they couldn’t help me.”
 
Then he called City of Hope.

CRITICAL TRIALS

A nurse who spoke with Dotson on the phone guided him to a clinical trial of a new hormone therapy designed to help rid the body of testosterone, which fuels prostate tumors.
 
“I didn’t know anything about clinical trials,” said Dotson. But he liked what he heard, and soon began taking the still-experimental drug, paired with regular injections of the standard treatment.
 
In taking that step, Dotson joined a vital community of City of Hope patients who not only receive leading-edge, potentially lifesaving, not-yet-generally-available therapies, but also earn praise and gratitude for doing so.
 
“My clinical trial patients are my heroes!” said Tanya Dorff, M.D., an internationally recognized leader in prostate cancer. Working closely with City of Hope research scientists, Dorff maintains an extensive clinical trials portfolio with a special emphasis on immunotherapy and the formidable potential of chimeric antigen receptor (CAR) T cell therapy. In the process, she treats many patients just like Dotson, and she knows how much she owes them.
 
“I’m so grateful for the value they add to my work,” she said. “And I honor the faith they have in me, the trust they’ve put in me. I can’t do any of this without them.”
 
City of Hope teams put approximately 1,000 new patients on therapeutic trials each year, and without those bonds of faith, trust and gratitude, none of it could happen.
 
That’s because patients who sign up for clinical trials are helping doctors and researchers gain critical knowledge not obtainable any other way.
 
Not surprisingly, people have misconceptions, and if you’ve ever thought about a clinical trial for yourself or a loved one, no doubt some of these fears have crossed your mind: The fear that you’ll be simply a “guinea pig,” that your doctor will care more about advancing the new drug than about you, that you’ll be given something dangerous or a placebo instead of a real treatment, or that clinical trials are only for “last resort” patients with nothing left to lose.
 
Wrong all around, say the experts.
 
“Our most important focus is the individual, not just the disease,” said Steven T. Rosen, M.D., City of Hope’s provost and chief scientific officer and the Irell & Manella Cancer Center Director’s Distinguished Chair. “While historically trials were experimental ‘last option’ procedures, we’ve evolved dramatically. Now they are an opportunity to provide the best therapies, to help our patients beat cancer and improve their quality of life.”
 
“Some of our most innovative trials right now target the early stages of disease,” added Dorff, who never looks at a patient as a guinea pig. “I’m super enthusiastic about every trial I run. I never ask a patient to do anything I don’t think will help, and I never give them anything I wouldn’t take myself or give to someone in my family.”
 
By the time a proposed treatment has reached the human trial phase, it has gone through years of rigorous research and testing, along with a slew of federally mandated procedures and protocols designed to protect patients every step of the way. For every potential drug that makes it to a clinical trial, about 1,000 do not. “Each of our trials has been vetted by a huge number of people,” said Dorff.
 
Placebos are being used less frequently in cancer trials, most commonly in scenarios where standard treatment alone is being measured against standard treatment and a new drug. Placebos are not used in place of effective cancer therapy. They are used to see whether a new drug improves success when added to standard treatment, or in situations where no effective treatment exists.

A SENSE OF URGENCY

City of Hope’s program is special because it was built with the same core values as the institution itself: an urgency to find the best treatments, a multidisciplinary approach, and an emphasis on leading-edge medicine, compassionate care, rapid bench-to-bedside research and always putting the patient first.
 
Even lab workers who never see a patient get the message.
 
“I always tell the research operations team, ‘Never assume your work isn’t patient-focused. Every time a clinician is with a patient, you’re in the room with them!” insisted Ashley Baker Lee, senior vice president of research operations. “Every one of our doctors is backed by hundreds of professionals who make it possible.”
 
Since joining City of Hope in 2012, Baker Lee has made it her mission to optimize the trials process in order to get more lifesaving drugs to more patients faster and more efficiently. Her job is maddeningly complex, painstaking and unending — reorganizing departments, building staff, dismantling data silos — but she’s seeing results. Five years ago, a typical trial activation timeline — how long it takes to process the many components involved with getting a trial started — could run seven months or longer.
 
City of Hope has reduced the time to fewer than 90 days.
 
“What we’re giving our patients is time,” she added, emphasizing that cancer patients can’t wait, and everything must be done to help them as rapidly as possible. The mission is personal to Baker Lee: She’s watched both parents struggle and pass away from cancer, and she herself has been on a clinical trial.
 
“If I can help move us forward to a cure, I’ll have made my mark.”

LABOR OF LOVE

For Dotson, the trials program was a perfect fit at the perfect time. The drugs he received lowered his PSA to zero and, nearly five years later, that’s where it remains. He’s still on the experimental treatment, he feels great and he’s optimistic about his future.
 
“I’m one of the lucky guys,” he said. “I know this drug may not always work, but the doctors have told me about even newer treatments in the pipeline.
 
“When I was at my lowest, City of Hope gave me hope. They’re really good at that. And now I feel like I could live forever!”

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