Back in January, TrialSite’s founder Daniel O’Connor spoke with Gary A. Ulaner, MD, PhD, FACNM, director of the Hoag Molecular Imaging and Therapy Program, about the emergence of Hoag Memorial Hospital as a major force in cancer research generally, and its move to become a leader in molecular imaging research, impacting not only Orange County, California, (“The OC”) but also the rest of the nation and beyond. Recall, Dr. Ulaner came out west at the invitation of Dr. Burton Eisenberg to implement a powerful Hoag vision, propelling the venerable Orange County-based nonprofit regional health care delivery network into a force for cancer research with multiple specialties, including molecular imaging & therapy. Dr. Ulaner came from Memorial Sloan Kettering Cancer Center where he led as the PET/CT expert on Breast Cancer and Myeloma Disease. With Ulaner at the OC came not only valuable standard of care expertise but also multiple innovative clinical trials, including a National Institutes of Health (NIH)-funded study using molecular imaging to detect cancer at the cellular level. Now Hoag’s Molecular Imaging & Therapy Program pioneers the most sensitive imaging and therapy approaches in a quest to advance research and more precise applications of molecular imaging and therapy. With the latest myeloma trial, Hoag is the only hospital in Orange County to provide the most sensitive cancer detection and therapy using nuclear medicine. Clinical trials led by Dr. Ulaner here at Hoag influence the future of cancer detection, precision therapy and even drug development in this field. TrialSite connected with Dr. Ulaner again to check in on progress and to learn more about this important Hoag-based research.
Multiple myeloma is a cancer that forms in a type of white blood cell called a plasma cell. While healthy plasma cells help an individual fight infections by making antibodies that recognize and attack germs, in multiple myeloma, cancerous plasma cells accumulate in the bone marrow and crowd out healthy blood cells.
According to the National Cancer Institute (NCI), over 34,000 new cases of myeloma will emerge in 2021 alone, along with unfortunately 12,410 estimated deaths. With a five year survival rate, the NCI estimated in 2018 that just under 150,000 people in America were living with myeloma.
Excerpts from the Discussion
TrialSite and Dr. Ulaner discussed two primary clinical trials on top of mind now at Hoag, including the innovative, investigator-initiated myeloma trial and one focusing on the important topic of prostate cancer.
What’s the importance of pioneering the CD38 myeloma trial?
The opening of the CD38 myeloma trial offers advanced cancer detection for the rare disease. Hoag is the first in the nation to offer this Phase 2 investigator-initiated study led by myself. This research investigates the use of a highly targeted molecular imaging agent in the earliest detection and location of a patient’s myeloma. The benefit? Positive results will lead the way for oncologists to obtain valuable earlier insight into more effective, less toxic, targeted treatment options addressing this deadly disease. Hence a form of targeted or precision-based care is now pioneered out of Hoag.
So, in this trial, the actual therapy is standard of care. While the research that can help myeloma care in the future, if we show positive results, is the addition of a novel immunoPET imaging test prior to and then following standard of care therapy in an effort to uncover if the novel imaging adds value over current measures of myeloma disease burden. And I have described that the current approach to measuring burden is suboptimal challenged as we cannot easily detect the cells.
Is there an industry sponsor here?
No. The study’s actually sponsored by Hoag Memorial Hospital Presbyterian with myself as Principal Investigator. So, it would be classified as an investigator-initiated study.
So there is no industry behind it—Hoag is driving the whole program?
That’s right. The clinical trial involves improving how we actually can evaluate myeloma. Again, right now it’s a suboptimal process in diagnosing multiple myeloma. This CD38 myeloma trial offers advanced cancer detection for this rare but deadly disease. Hoag is actually the first hospital/research site in the nation to offer this Phase 2 clinical trial.
The goal of this effort is to improve myeloma treatment planning and evaluation of residual disease following treatment. We are using 89Zr-DFO-daratumumab, a novel immunoPET tracer which is designed to detect CD38 on myeloma cells. This can enable visualization of myeloma in the PET scanner.
What about the Phase 1 study?
We completed that at MSK. The results demonstrated safety and successful visualization of myeloma with the novel imaging agent.
How many patients will this Phase 2 trial require?
60 patients. 30 at Hoag and 30 at University of Miami
Are you on track?
Yes. We have two patients enrolled now. COVID-19 obviously had an impact. The study started in March and its estimated primary completion is March 2024.
What about the Prostate trial?
This is an industry sponsored trial called the “ARROW” trial with a formal title of “Study of I-131-1095 Radiotherapy in Combination with Enzalutamide in Patients with Metastatic Castration-resistant Prostate Cancer Who are Chemotherapy Naïve and Have Progressed on Abiraterone.” In this multicenter study led by Progenics, we investigate the safety and efficacy of an novel treatment of I-131-1095 radiotherapy combined with a drug called enzalutamide compared to enzalutamide alone in patients with prostate-specific membrane antigen (PSMA).
In this particular study ,we evaluate a promising novel therapy against a type of prostate cancer known as prostate-specific membrane antigen (PSMA)-avid metastatic prostate cancer. Here, novel agents such as the one in this study show incredible promise in helping to prolong a patient’s lives while also serving to improve quality of life. Hoag is excited to be part of this trial.
The Prostate Cancer Sponsor
Progenics, the named sponsor, is actually now part of Lantheus, a global leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and products.
TrialSite wanted to learn more about how Dr. Ulaner was adapting to Southern California and the prospects to build an even bigger cancer research center at Hoag.
How is life in The OC? It is certainly different to New York City.
This was absolutely the right choice. My family and I are really enjoying life here and Hoag is a wonderful place to work.
Of course, this part of Southern California, with miles of beaches, mountains and culture everywhere, usually fails to disappoint.
What about going from an intellectually intense, the research-rich world of Manhattan to a more spread out and distributed Southern California?
Well it’s very different. Manhattan is a highly densely populated place, highly concentrated, with so many academic medical centers near each other you can literally walk from one research center to another. Obviously, that’s not feasible here but with online conferencing during the pandemic, virtual collaboration becomes very much the norm. Along with Hoag, with prominent research institutions here in Southern California (USC, UCLA, City of Hope, etc.), enormous potential for collaboration and teaming is facilitated by today’s modern communications technology. Southern California when combining all of the expertise, talent, and facilities represents a globally relevant research location.
What’s important about your experience at Hoag thus far?
It’s a fantastic place with wonderful people and great support. I think the most important thing is that the vision of Dr. Eisenberg aligned with my goals and objectives, and the support is here to execute and make it a reality. I feel the support here, the leadership backs the effort, which is key. We want to make Hoag a center for molecular imaging and therapy, and we are doing just that now.
What does it take to build the future of Hoag as the preeminent center of science-based research, precision care and individualized treatments?
It takes the vision and organizational commitment, which is here. Hoag already conducts a couple hundred clinical trials and its that vision that brought me here to work with Dr. Eisenberg. Then we expand with more talent, studies and collaborative partnerships. And as we grow and build, my goal will be to have this take off, so I am in fact not even needed any more. That’s when I know I did my job.
Do you think it’s important for Hoag to partner with other institutes?
Absolutely. The enemy is cancer. Its us vs. cancer. Collaboration makes all the sense in the world.
What’s Dr. Ulaner’s philosophy on care?
Truth. This top cancer research and care giver leads a war against cancer. He emphasized in a recent Hoag video that full disclosure and transparency, sharing with cancer patients all information, is important in building the important bond between doctor and patient. Dr. Ulaner’s on a mission to eradicate cancer from his specific field of molecular imaging and therapy.
About the Hoag Molecular Imaging & Therapy
Hoag’s Molecular Imaging & Therapy Program is the only one of its kind in Orange County, which builds on Hoag’s personalized, science-based approach to cancer care. Hoag now helps to pioneer the most sensitive imaging methods to data in a bid to advance research and applications of molecular imaging and therapy in the treatment of cancer patients. Ongoing clinical trials are expected to play a significant role in cancer detection, individualized treatment and drug development. It’s not an exaggeration to declare that the future of cancer detection and therapy is now offered at Hoag in support of the clinical research as a care option movement.
Call to Action: If you or a loved one has been diagnosed with myeloma and are based in Southern California, consider contacting Hoag to learn more about the relevance of this research.