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.

group of medical professionals

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

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