SCOPE opens doors to early-phase clinical trials
Citywide program unique in the U.S.
The history of cancer is filled with promising therapies that ultimately provided only marginal benefits.
When Lodi resident Victoria Pouchés (pronounced poo-SHAY) was told by her primary care physician that she had run out of treatment options for her ovarian cancer, she sought help from the UC Davis Comprehensive Cancer Center. She had received her initial care there from Edwin Alvarez, a gynecological oncologist, and hoped he might offer something new. After three years of battling the disease with surgery and multiple rounds of chemotherapy, Pouchés had developed heart damage, and her cancer was growing.
Alvarez, associate professor in the Department of Obstetrics and Gynecology, quickly entered Pouchés into a Phase I clinical trial for a new cancer treatment that taps into the patient’s own immune system to mount a response and fight the cancer.
“Instead of hospice, I am now part of this cutting-edge treatment,” says Pouchés, who is currently undergoing infusions every two weeks as part of the experimental protocol. “I can’t tell you how fortunate I feel.”
Phase I clinical trials are unique, says Thomas Semrad, UC Davis assistant professor of internal medicine in the Division of Hematology and Oncology. Often the first time that a new drug or drug combination will be tested in humans, the studies are designed to determine if the therapy is safe and at what dosage it can be tolerated. For patients like Pouchés with a cancer that wasn’t stopped with standard therapy, participation in a clinical trial of a promising new treatment can be a lifeline.
But conducting such trials is extremely costly, adds Semrad, and the UC Davis Comprehensive Cancer Center is the only facility in the region with the capability to do so. Because the effects of new treatments are inherently uncertain, the safeguards in place to conduct Phase I clinical trials are much more extensive than for later-stage clinical trials, he explains. Patients are monitored extremely closely to ensure that they are tolerating the new therapy. At the same time, frequent imaging and physiological tests are typically conducted to determine whether the treatment is having the desired effect of fighting the tumor.
“Phase I trials are among the most intensive stages in new drug development,” says Semrad, who runs the Phase I program with Karen Kelly, associate director for clinical research at the cancer center. “There may be only 20 patients in an individual study, but the behind-the-scenes work to ensure participant safety and that we learn as much as possible about the new therapy can be more intense than for a large trial.”
Finding appropriate patients to participate also can pose a challenge because participants must have already undergone — and failed — standard therapies. And because some treatments are designed to treat rare cancers, finding enough patients for a trial can be difficult.
Cancer Center Director Ralph de Vere White understands these challenges, and with them saw an opportunity to expand the reach of the center’s Phase I trials to a broader population of patients in the region, and offer hope to more people. In April of 2012, de Vere White took his idea to the editorial board of The Sacramento Bee, which later published an editorial promoting a citywide program to “increase the number of and quality of clinical trials” and to “make a dent in the fight against cancer.”
Today, that vision is a reality. Semrad and Kelly developed a regional effort known as SCOPE (Sacramento Citywide Oncology Phase I program), the first collaboration of its kind among physician partners from the major health care systems throughout Sacramento to share patients and clinical resources with the goal of providing more Phase I clinical trials to the area.
Started in the spring of 2015, the SCOPE partnership already has exceeded goals for enrolling patients in clinical trials, with 112 participants in Phase I trials in 2015 (up from fewer than 100 before the program), and the expectation of eventually conducting trials on some 150 patients annually. Patients stay with their regular doctors and return to their home hospitals after participating in their clinical trial.
Deepti Behl, an oncologist at Sutter Health, has referred patients to Phase I clinical trials and is an active participant on the SCOPE committee.
“I’m extremely interested in seeing this program grow and succeed,” she says. “Anything that makes participating in clinical trials more seamless for our patients is a great thing.”
Semrad added that everyone wins with SCOPE.
“The bigger our pool of patients, the likelier it is that we can fund new studies,” says Semrad. “And more studies bring better patient access to promising treatments and a better chance that we will find more effective therapies for difficult-to-treat cancers.”
Semrad notes that the UC Davis Comprehensive Cancer Center is in an optimal position to attract patients for clinical trials of experimental therapies. The only National Cancer Institute-designated Comprehensive Cancer Center in Northern California outside of the Bay Area, the cancer center serves an enormous geographic area encompassing Northern California and the Central Valley, with a population of more than 5 million.
“SCOPE is the only one of its kind I know of in the country,” says Semrad. “Rather than a referral network, this is a real partnership between different medical facilities, all working toward the better health of the community and advancing cancer research.”
Semrad hopes that in future years, SCOPE will result in more partnerships with more health care institutions, the National Cancer Institute and industry. All have stakes in providing patients with better access to Phase I clinical trials.
Bob Rose, a community member who serves as a patient advocate with SCOPE, also thinks that combining community area healthcare resources is invaluable for patients in the area. A cancer survivor himself, Rose and his wife run a weekly support group in their home for people with cancer.
“The people who come to our meetings are desperate to learn of new options,” says Rose. “They are constantly looking for a trial that they might fit into.”For the 60-year-old Pouchés, the trial she found was a perfect fit. Many of her symptoms have disappeared, and she was recently told that the cancer biomarkers in her blood have dropped to negligible levels, indicating that the cancer is in remission. “My overall quality of life has improved 100 percent,” she says. “I have gone from bedridden to now being able to go for walks in the park every morning. I am very blessed.”