TRACK study to assess precision medicine in rare cancers
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Precision medicine in cancer treatment has gained momentum due to advances in genomics and the mechanisms of targeted therapies.
However, patients with rare cancers — defined as those that occur among less than six per 100,000 people each year in the United States — have not been able to access the full benefit of these advances.
“These cancers are individually rare, but if you put them all together, they make up almost 25% of the cancer burden, and they are a real unmet need,” Razelle Kurzrock, MD, distinguished professor of medicine, associate director of clinical science and director of the Center for Personalized Cancer Therapy and the Rare Tumor Clinic at Moores Cancer Center at University of California, San Diego, said in an interview with Healio. “Because of their rarity, they sometimes don’t have FDA-approved therapies — and even if they do, it’s usually only one therapy. It’s different than with breast cancer, where there are so many approved therapies. There also is a paucity of trials for these patients.”
In response to this unmet need, Kurzrock and colleagues have launched the TCF-001 TRACK study, which will provide access to precision medicine for patients with rare cancers. The trial will utilize remote consent, which will enable patients to obtain genomic information and personalized treatment recommendations without the usual travel to an academic medical center.
Today, in conjunction with Rare Cancer Day, TargetCancer Foundation, the trial’s sponsor, announced the first patients have been enrolled.
Kurzrock spoke with Healio about how the TRACK study will facilitate tailored treatment plans for its participants, and what it might mean for the future of rare disease treatment.
Question: How did this project come about?
Answer: We started the Rare Tumor Clinic at University of California, San Diego, and I also oversee the Early Therapeutics and Rare Cancers Committee of NCI’s SWOG Cancer Research Network. So, a precision medicine rare cancer study was a natural fit when we had an opportunity through the TargetCancer Foundation to do a national rare tumor study.
Q: How many rare cancers will you study, and what are some of those cancers?
A: There isn’t a limit; it’s open to any tumor that meets the rare cancer definition. Some of the better-known rare cancers might be cholangiocarcinoma; some of the less well-known might be ultra-rare tumors like ameloblastoma. There is a wide variety of these tumors.
Q: Has there been much research into treating these cancers with precision medicine?
A: Not much has been done. Our NCI SWOG Early Therapeutics and Rare Cancer Committee has a national immunotherapy trial called DART for these patients. However, the TRACK study will focus on genomic-based precision medicine. One of the challenges is that these cancers are so rare that doing an individual study for each one is very difficult. However, if you put them all together into a single study, it will allow us to rapidly get data, and it’s more realistic and more helpful.
Q: What is the study methodology?
A: We are looking to enroll about 400 patients and will have different locations for the study, including not just academic centers such as University of California, San Diego and The University of Texas MD Anderson Cancer Center, but also community sites. There will be a molecular tumor board and we will individualize the therapy options based on high-quality sequencing. The molecular tumor board will make the recommendations. That’s important because there needs to be some expertise with these recommendations. Not all physicians are comfortable with sequencing. We want to be helpful to those physicians, as well.
Q: Could this lead the way to more studies, and ultimately new treatments that could become standard of care for some of these rare tumors?
A: That is possible. The first thing we would look at is how our strategy works across tumors. Is there efficacy in this strategy of individualizing care based on the genomic and immune portfolio? If we see very good responses in a certain group of patients, we could always expand that group and get more information.
Q: Is there anything else you would like to mention?
A: Another important aspect of this study is that we’re trying to do this at multiple sites and include community sites. We’re hoping because of that, patients will have an opportunity to enter this trial without having to travel far to get to the trial site. They will be able to go to a place that is relatively local. We know that’s very important to patients with cancer.
For more information:
Razelle Kurzrock, MD, can be reached at 3855 Health Sciences Drive, La Jolla, CA 92093; email: rkurzrock@ucsd.edu.
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