Advancing Science for the Common Good
Saving lives and improving health are at the heart of ever-expanding UC Irvine clinical trials
By Victoria Clayton
Advancing Science for the Common Good
Saving lives and improving health are at the heart of ever-expanding UC Irvine clinical trials
By Victoria Clayton
Dr. Daniela Bota, UC Irvine professor of neurology and vice dean for clinical research, knows that medicine has progressed exponentially on many fronts in just the past decade. Despite these significant advancements, she remains focused on what’s left to do: “We still have a plethora of disorders for which we don’t have a good treatment or any way to cure them. Just considering the burden of cancer and neurological disorders, the need for better treatment is staggering.”
Enter clinical research. These studies help determine if a new treatment is safe and effective and better than an existing standard of care. The trials can include behavioral interventions, devices, drugs or surgical procedures. Another form of research – observational studies – gathers information about participants over time. These may not introduce an intervention but could still help researchers identify treatments or prevention strategies to test later in trials.
In recent years, UC Irvine has expanded clinical research to bring groundbreaking healthcare and discovery to Orange County.
“We’ve been growing our trials at UCI by leaps and bounds,” says Shauna Stark, director of research operations at the School of Medicine. “Over the last five years of so, we’ve brought more manpower to trials than we’ve ever had before. We’ve also increased efficiency and knowledge by bringing trials together more centrally. And we’ve been growing our faculty, especially in the School of Medicine.”
She adds: “We’re promoting a culture of research – which makes sense because the research piece is what’s special about an academic institution.”
Indeed, UC Irvine is committed to fostering “bench to bedside” science, taking scientific discoveries in the lab all the way to trials and, hopefully, to patients.
We're promoting a culture of research - which makes sense because the research piece is what's special about an academic institution.
“The need for better treatment is staggering,” says Dr. Daniela Bota (right), UC Irvine neurology professor and vice dean of clinical research.
We're promoting a culture of research - which makes sense because the research piece is what's special about an academic institution.
“The need for better treatment is staggering,” says Dr. Daniela Bota (right), UC Irvine neurology professor and vice dean of clinical research.
We're promoting a culture of research - which makes sense because the research piece is what's special about an academic institution.
“The need for better treatment is staggering,” says Dr. Daniela Bota (right), UC Irvine neurology professor and vice dean of clinical research.
Lifesaving Treatment Development
The heart of UC Irvine’s clinical research is four-pronged: the Stern Center for Cancer Clinical Trials and Research (oncology clinical trials), the Center for Clinical Research (a multidisciplinary center for non-oncology trials), the Alpha Clinic (stem cell and gene therapy trials) and UCI MIND (dementia trials).
Trials at UC Irvine are supported by many sources, including the National Institutes of Health, the California Institute for Regenerative Medicine, philanthropic gifts and, in some cases, drug companies that are engaged in testing novel treatments and require multiple centers to complete their research.
Why should patients take part?
Of course, the point of a trial is to advance science for the common good. This is the lifeblood of an academic research institution like UC Irvine. People not familiar with scientific research, though, may believe that being part of a trial means they are the quintessential “guinea pig.” Stark says nothing could be further from the truth. Before a study can even begin, it’s subject to intense vetting by something called an institutional review board. All studies are required to protect participants in the research and comply with myriad regulations, ethical standards and UCI Health policies. In fact, by and large, being part of a clinical trial confers benefits – sometimes lifesaving – to the individual participant.
Offering Glioblastoma Patients a Fighting Chance
UC Irvine professor and neuro-oncologist Daniela Bota’s lab is part of a number of collaborative efforts to identify new targets for cancerous brain tumor immune therapies, including a multi-institutional, multinational effort to design a new tumor vaccine. Other clinical trials Bota is involved in explore the use of dendritic cell vaccines and CAR-T cell immune therapy to fight glioma. In addition, Bota’s lab focuses on the clinical translation of specific, targetable tumor pathways in malignant glioma stem cells. The team’s translational research has directly led to clinical trials using proteasome inhibitors to improve survival in newly diagnosed and recurrent glioblastoma patients.
A clinical trial offers people an opportunity to have a treatment that researchers already strongly suspect could work better than the standard-of-care treatment. “Patients don’t receive care that’s less than what they would’ve received outside the trial,” says Dr. Farshid Dayyani, professor of clinical medicine in hematology/oncology and associate director of translational science for UC Irvine’s Chao Family Comprehensive Cancer Center. And because these individuals are part of a study, they benefit from increased scrutiny and, typically, a lot more care.
Dayyani notes two recent UC Irvine studies that he’s worked on that have resulted in patients doing well today who may not be alive had they not participated. Dr. Nadine Abi-Jaoudeh, professor of clinical radiology and director of clinical research in radiological sciences, and Dayyani teamed up on a novel treatment for liver cancer. They primed the immune system of liver cancer patients who participated in the study with immunotherapies, followed by interventional radiology to eliminate the blood supply of their tumors and additional targeted therapy.
“We had patients with large tumors who should have lived maybe eight to 10 months who are now 23 months in remission,” Dayyani says. “They are now coming only to see us for surveillance.” In a separate study, surgical oncologist Maheswari Senthil and Dayyani partnered to offer a novel treatment to patients with extremely aggressive stomach cancer. Called the Stopgap study, the innovative Phase 2 clinical trial gave patients immunotherapies, followed by chemotherapy directly into the abdomen and then surgery. It’s the only U.S. clinical trial to have used all three treatment modes for advanced gastric and gastroesophageal adenocarcinomas.
Says Dayyani: “Years later, about one-third of our patients – these are people who were given a prognosis of nine months to live – are disease-free.”
Dr. Farshid Dayyani (right), professor of medicine in hematology/oncology and Dr. Maheswari Senthil, surgical oncologist and medical director for the UCI Center for Clinical Research
Years later, about one-third of our patients – these are people who were given a prognosis of nine months to live – are disease-free.
- Dr. Farshid Dayyani, professor of medicine in hematology and oncology
Expanding the Possibilities for GI Patients
Dr. Farshid Dayyani, UC Irvine hematology/oncology professor, is involved in a range of multidisciplinary, cutting-edge trials that aim to extend the lives of – and sometimes render disease-free – patients with colorectal cancer and cancers of the stomach, esophagus, liver and gastrointestinal tract. In fact, he and his colleagues have made UC Irvine one of the leading academic institutions for GI trials in California. Says Dayyani: “Through our trials with liver cancer and many other GI cancers, UCI really has helped improve the standard of care for patients everywhere.”
Championing Sight-Saving Stem Cell Treatments
Dr. Henry Klassen, UC Irvine professor of opthalmology, and his colleagues are approaching Phase 3 clinical trials for a first-of-its-kind stem cell-based treatment for retinitis pigmentosa, a group of rare genetic eye diseases that affect the retina (the light-sensitive layer of tissue in the back of the eye) and lead to blindness. Klassen’s clinical research is the impetus behind Newport Beach-based jCyte, a clinical-stage biotech company he helped launch to develop cures for retinal degenerative disorders.
Detecting Lung Cancer Earlier to Save Live
Dr. Hari Keshava, UC Irvine assistant clinical professor of thoracic surgery, is studying the impact of screening immediate family members of patients with lung cancer due to a genetic mutation. Data suggests that certain mutations may be genetically transmissible, especially among Asian women. His study aims to learn whether lung cancer can be inherited and if screening family members will help find lung cancer earlier. So far, the majority of lung cancer is deadly because it’s discovered too late. When found early, however, lung cancer may be curable.
Expanding the Possibilities for GI Patients
Dr. Farshid Dayyani, UC Irvine hematology/oncology professor, is involved in a range of multidisciplinary, cutting-edge trials that aim to extend the lives of – and sometimes render disease-free – patients with colorectal cancer and cancers of the stomach, esophagus, liver and gastrointestinal tract. In fact, he and his colleagues have made UC Irvine one of the leading academic institutions for GI trials in California. Says Dayyani: “Through our trials with liver cancer and many other GI cancers, UCI really has helped improve the standard of care for patients everywhere.”
Championing Sight-Saving Stem Cell Treatments
Dr. Henry Klassen, UC Irvine professor of opthalmology, and his colleagues are approaching Phase 3 clinical trials for a first-of-its-kind stem cell-based treatment for retinitis pigmentosa, a group of rare genetic eye diseases that affect the retina (the light-sensitive layer of tissue in the back of the eye) and lead to blindness. Klassen’s clinical research is the impetus behind Newport Beach-based jCyte, a clinical-stage biotech company he helped launch to develop cures for retinal degenerative disorders.
Detecting Lung Cancer Earlier to Save Live
Dr. Hari Keshava, UC Irvine assistant clinical professor of thoracic surgery, is studying the impact of screening immediate family members of patients with lung cancer due to a genetic mutation. Data suggests that certain mutations may be genetically transmissible, especially among Asian women. His study aims to learn whether lung cancer can be inherited and if screening family members will help find lung cancer earlier. So far, the majority of lung cancer is deadly because it’s discovered too late. When found early, however, lung cancer may be curable.
Hope for the Most Difficult Cases
Bota’s focus is glioblastomas, which are extremely aggressive and deadly brain tumors. “It’s one of the many conditions for which there haven’t been great standard-of-care treatments,” she says. Again, at UC Irvine, clinical trials have offered not just hope but possibility in the form of cutting-edge medical care and novel treatments.
In one of Bota’s trials, newly diagnosed glioblastoma patients were treated with chemotherapy, radiation and an experimental drug called marizomib, which can penetrate the blood-brain barrier and inhibit cancer growth without causing damage to other parts of the brain. Traditional chemotherapy can’t do this. With standard-of-care treatment, glioblastoma patients typically succumb to the disease in less than a year. Some of Bota’s clinical trial patients have lived more than two years and are still doing well.
Bota explains that when people are facing daunting medical diagnoses, it’s more than the disorder they’re up against. The financial component of tackling a grave medical condition can feel insurmountable. Having the best possible treatment close to home sometimes makes all the difference. “Many people could not take part if they had to travel somewhere to get access to trials. So the fact that UCI has been expanding access right here in Orange County is a huge benefit to our community.” (The UCI Health Chao Family Comprehensive Cancer Center in July opened a clinical hub in Irvine to complement the one in Orange.)
Providing Better Care for Stem Cell Transplant Patients
Hematologic oncologist Piyanuch Kongtim, UC Irvine associate clinical professor, is on a mission to change the standard of care for stem cell transplant patients. An infection called cytomegalovirus is one of the major complications that can happen after transplant. The current standard of care is to give transplant patients antiviral drugs for 100 days following their transplant to prevent CMV. Kongtim and colleagues have a clinical trial testing the feasability of using a CMV T cell immunity panel – a blood test that measures the strength of a patient’s T cell immune response specifically against cytomegalovirus – to pinpoint more accurately the amount of time transplant patients should take the antiviral drugs. “In general, practitioners are not aware that there could be a benefit to administering the drugs beyond the 100 days,” Kongtim explains. “We want a way to determine the readiness of the patient to stop medication.” The aim is to explore ways to offer safer transplants and reduce post-transplant complications. Even a small change in post-transplant protocol could make a big difference, especially in cases where the donor and recipient may not be perfect matches. Says Kongtim: “When we publish, people from other centers will use our research as a reference to change the clinical practice.”
Dayyani points out that the benefits extend well beyond the patient or the patient’s family. There’s an impact on the entire Orange County region. “When I started at UCI in 2016, the cancer clinical trials maybe had 20 to 25 full-time employees. Now we have 120-plus, and we still have open positions,” he says, citing the need for trial coordinators, financial analysts, regulatory coordinators and much more. “Running clinical trials is a very big team effort. And that’s good for everyone who lives here.”
What’s more, UC Irvine researchers aim to make clinical trials even more accessible with the Irvine medical campus, slated to open this year, and the newly acquired Fountain Valley Regional Hospital, Lakewood Regional Medical Center, Los Alamitos Medical Center and Placentia-Linda Hospital.
“Clinical research has always been a sort of ‘you come to us’ model, but that’s changing,” Stark says. “As UCI stretches out over more of Orange County, we’re going to be able to bring opportunities to participate in clinical trials out to the community.”
Know More, Get Involved In
Clinical Research
If you’re currently a patient of UCI Health, you may receive notices through your health portal about opportunities to take part in research, or your healthcare provider may make you aware of them. If not, ask your doctor if there are clinical research opportunities you should be aware of – especially if you have a serious condition or cancer. But anyone, UCI Health patient or not, can participate. To learn more about UC Irvine’s clinical research, email questions to the Stern Center for Cancer Clinical Trials and Research at ucstudy@hs.uci.edu or call 877-827-8839.
Understanding Clinical Research Phases
Clinical research falls into two main categories: observational studies, in which an intervention is not involved, and clinical trials, which involve an intervention (i.e., drugs, devices, surgery, behavioral intervention or a combination of these). Studies can also be large, multisite endeavors sponsored by a pharmaceutical company or device developer, for example, or led by UC Irvine investigators, which often means that they’re only available at UC Irvine. Strict patient protections and safety protocols are enforced regardless of the study type. Many offer patients some compensation for the time and effort required to participate. If the study is a clinical trial, it’s conducted in progressive steps called phases, which usually take many years:
Preclinical Trial
Preclinical research includes everything from basic science to investigating the causes of the disease to testing possible treatments in animals. Any treatment that makes it to a human clinical trial has a bevy of good preclinical research behind it.
Phase 1 Trial
Researchers test a drug or treatment with a small group of participants (20 to 80 people) for the first time to learn about safety and dose range. These are often called first-in-human trials.
Phase 2 Trial
The number of participants is expanded (100 to 300 people) to study effectiveness and to further study safety.
Phase 3 Trial
The new drug or treatment is given to large groups of participants (1,000 to 3,000 people) to confirm effectiveness, ascertain side effects, compare it with standard treatments or similar ones, and collect safety data.
Phase 4 Trial
After a drug is approved by the U.S. Food and Drug Administration and made available to the public, researchers continue tracking safety in the general population, gleaning more information about optimal use. Of all the drugs that enter clinical trials, less than 10 percent ultimately gain FDA approval.
Understanding Clinical Research Phases
Clinical research falls into two main categories: observational studies, in which an intervention is not involved, and clinical trials, which involve an intervention (i.e., drugs, devices, surgery, behavioral intervention or a combination of these). Studies can also be large, multisite endeavors sponsored by a pharmaceutical company or device developer, for example, or led by UC Irvine investigators, which often means that they’re only available at UC Irvine. Strict patient protections and safety protocols are enforced regardless of the study type. Many offer patients some compensation for the time and effort required to participate. If the study is a clinical trial, it’s conducted in progressive steps called phases, which usually take many years:
Preclinical Trial
Preclinical research includes everything from basic science to investigating the causes of the disease to testing possible treatments in animals. Any treatment that makes it to a human clinical trial has a bevy of good preclinical research behind it.
Phase 1 Trial
Researchers test a drug or treatment with a small group of participants (20 to 80 people) for the first time to learn about safety and dose range. These are often called first-in-human trials.
Phase 2 Trial
The number of participants is expanded (100 to 300 people) to study effectiveness and to further study safety.
Phase 3 Trial
The new drug or treatment is given to large groups of participants (1,000 to 3,000 people) to confirm effectiveness, ascertain side effects, compare it with standard treatments or similar ones, and collect safety data.
Phase 4 Trial
After a drug is approved by the U.S. Food and Drug Administration and made available to the public, researchers continue tracking safety in the general population, gleaning more information about optimal use. Of all the drugs that enter clinical trials, less than 10 percent ultimately gain FDA approval.
Bringing Mindfulness and Health Education Online
Sean Young’s trials involve the Harnessing Online Peer Education intervention, an online, peer-led community for behavioral change in people at risk for HIV, substance use disorder and mental health issues. The UC Irvine professor of emergency medicine and informatics’s team studies the impact of teaching online peer role models the science behind how to spread sound information and encourage healthy change. Young says: “So far, what we’ve found is that patients – even with challenges such as opioid use disorder – would rather receive information about treatment from their peers than from health providers.” He recently also launched pilot studies investigating whether mindfully listening to different types of music can decrease chronic pain and improve mental health.
UC Irvine Magazine is produced by the Office of Strategic Communications & Public Affairs.
To contact the editor, email ucimagazine@uci.edu.