Clinical Research
OVERVIEW
Hoag Family Cancer Institute strives for a commitment to exceptional patient
care by offering a robust portfolio of clinical trials, many of which
are testing novel cancer agents. Through an alliance with USC Norris Comprehensive
Cancer Center, Hoag has also built upon this clinical trials program,
offering phase I clinical trials, unlike most other community hospital programs.
Deborah Fridman, Psy.D., R.N., director of Clinical Research and Leila
Andres, M.S., program manager for Cancer Clinical Research, lead a team
of highly educated clinical research coordinators who collaborate with
industry sponsors, institutional review boards, physicians, pharmacy,
infusion nurses and staff, as well as other areas of the hospital to open
and enroll patients on cancer clinical trials.
Additionally, several of Hoag’s medical oncologists have unique expertise
in utilizing novel agents in cancer treatment as well as in the acquisition
of these novel agents. They emphasize participation in and identification
of optimal clinical trials for Hoag’s patients.
EARLY PHASE CLINICAL TRIALS (Developmental Therapeutics Program)
Over the last several years there has been a shift in early phase cancer
clinical trials – what used to be testing new agents to understand
their safety and toxicity has progressed to testing agents that in many
cases, extend life or offer a more effective treatment option for advanced
cancers than standard therapies.
At least 80% of cancer care is delivered in the community setting1 and yet, few community-based cancer programs can offer access to these
novel drugs.
In 2013, Hoag Family Cancer Institute established an alliance with USC
Norris Comprehensive Cancer Center, a National Cancer Institute designated
comprehensive cancer center, to expand access to subspecialized cancer
physicians and clinical research. The academic affiliation positioned
Hoag to open first in man, phase Ia, Ib, and phase II clinical trials
. These new agents, which are more targeted and, in many cases, take advantage
of the patient’s own tumor genomic profile, are available on a very
limited basis and typically only at academic medical centers. Trials can
be cancer disease site specific or target specific, applicable to patients
with different types of cancer.
Hoag is the first and only community hospital in Orange County to offer
phase I clinical trials.
In 2017, Hoag grew its phase I and II industry sponsored clinical trials
portfolio significantly as part of the effort to have a study available
for every patient – every indication, every phase, every stage.
Fifteen phase I and II clinical trials opened in 2017.
Recent breakthroughs in the understanding of the molecular characteristics
of tumors have led researchers to discover the mechanisms by which cancer
hides from the immune system. Such discoveries have led to significant
improvement in immuno-oncology drugs that activate the immune system to
detect and destroy cancer cells. Newer monoclonal antibodies (mAbs) and
checkpoint inhibitors targeting PD-1 and PD-L1 are becoming available
in early phase clinical trials, and some of these new agents are being
tested in combination with other cancer drugs. In response, we have focused
on opening some of the most promising immunotherapy trials at Hoag Family
Cancer Institute to bring advances to patients in real time.
PHASE III AND IV TRIALS
Hoag Family Cancer Institute leads and participates in phase III and IV
trials including registry trials in early detection and early intervention
for malignancies such as pancreatic and lung cancer, programs for defining
cancer risk, as well as an active surveillance program for those diagnosed
with low-grade prostate cancer. These efforts will inform future methods
of treating cancer and the optimal intervention for individuals and families
at increased risk of developing cancer, while expanding patients’
options today.
PRECISION MEDICINE CLINICAL RESEARCH
Developments in genomics and the understanding of the molecular characterization
of cancer have launched a new era of cancer research and drug development.
Hoag Family Cancer Institute has partnered with Caris Life Sciences for
molecular profiling of patients’ tumors to identify actionable mutations
and apply targeted therapies. Our partnership includes participation in
the growth of a national registry of patients’ genetic mutations
and outcomes from the use of targeted treatments. Registries such as this
standardize and collect outcomes data that can provide valuable information
for other clinicians as well as build upon a body of evidence important
for developing future treatments. (Additional information can be found
in the Precision Medicine section of this report.)
A complete list of clinical trials can be found at the end of this report.
For an up to date list of clinical trials currently open, contact Leila
Andres, M.S., at 888-862-5318.
1 Cancer Care Migrate to Oupatient Settings. The Journal of Healthcare
Contracting www.jhconline.com/cancer-care-migrates-to-outpatientssetting-2.html
ACCESS TO CLINICAL TRIALS AND COMPASSIONATE CARE TURNS CANCER INTO ‘AN
ADVENTURE’
Bob Siemon coins most conversations about his now five-year battle with
stage 4 color ectal cancer as ‘an adventure.’ By the time
doctors found Bob’s cancer, it had metastasized to his lungs. He
was given a 5 percent chance of survival. “I told the doctor, ‘If
there is a 5 percent survival rate, then you’re looking at one of
the 5 percent. I’m going to beat this thing.’”
To do that required going above and beyond the traditional modes of treatment.
Bob initially spent a year traveling regularly from his home in Newport
Beach to Los Angeles for treatment. In 2016, Bob was referred to Diana
Hanna, M.D., a medical oncologist closer to home, who runs Hoag’
Phase 1 Clinical Trials Program. Hoag offers university-like care with
access to Phase 1 clinical trials, unlike any other community hospital
in the area.
“She was so loving and so nice and smart and caring – and she’s
just down the street,” Bob said. The change in location was life-altering
for Bob, not just because the drive was shorter but because Hoag offered
something extraordinary that other facilities can’t match.
“At Newport Beach, you get Fran the greeter, who gives you a hug
every time you come in. It’s just so positive,” he said. “I
am so grateful for what my LA doctors provided for me, but at Hoag, they
make it so easy and nice, it’s unbelievable.”
After additional prescribed radiation treatment at Hoag, Dr. Hanna entered
Bob in his second clinical trial for a targeted therapy. Bob did not respond
well to the treatment and had to be taken off the trial, but he is grateful
for the access to innovative treatment options. And when Dr. Hanna presented
him with a third clinical trial opportunity, Bob did not hesitate. “You
have to throw everything you have at this cancer.”
The new trial is a Phase 1 clinical trial that is usually only offered
in university research settings. This Phase 1 trial is one of many that
are available at Hoag, for many different types of cancer. It seems to
be working. “Four months ago, I had a 35 percent reduction in all
my tumors. I couldn’t believe it. Up until then, the tumors either
slowed down or got bigger.”
While Bob’s journey is not yet behind him, he is grateful to have
gotten this far.
For more information call:
949-722-6237