Patients with rare cancers often face limited options for treatment, particularly given the fact that it is challenging to design clinical trials that enroll enough patients with these rare cancers to thoroughly test new therapies. This is very much the case for many brain cancers, which tend to be rare, deadly, and resistant to typical cancer therapies. In an effort to help counter this trend, Baylor Scott & White Research Institute (BSWRI) is actively pursuing research aimed at bringing more trial opportunities, and ultimately, potential future treatment options to patients with cancers of the brain. A notable advantage that BSWRI brings to this effort is its ability to link multiple sites across the Baylor Scott & White system under their clinical trials. In doing so, BSWRI is able to engage a more diverse population, and therefore more potentially eligible patients, across not only in the state of Texas, but neighboring states.
These efforts are already helping to accelerate research progress for the highly aggressive grade III and IV gliomas. Considerable attention has focused on glioblastoma, a grade IV glioma, which is the most common form of primary brain cancer. However, newer trials are starting to investigate strategies for treating grade III gliomas as well.
To identify new therapies for grade III gliomas, BSWRI is enrolling patients in the STELLAR trial, a multicenter randomized phase 3 open-label study of eflornithine with lomustine compared to standard-of-care lomustine monotherapy as a second-line treatment in patients with progressive or recurrent anaplastic astrocytoma. The primary outcome measure is overall survival. Utilizing its footprint, BSWRI has linked two sites for this study to engage more potential patients. Patients can enroll at either Baylor Scott & White Medical Center in Temple, TX, or at Baylor Scott & White’s Charles A. Sammons Cancer Center in Dallas, TX.
Anaplastic astrocytoma is a rare malignant glioma with a five-year survival rate of 27%. According to CBTRUS, the yearly incidence is approximately 0.4 per 100,000 people in the US. Standard treatment involves surgery, radiation, and chemotherapy, and the treatment options are limited for patients with recurrence. No targeted therapies are available for anaplastic astrocytoma.
The Principal Investigator for the Dallas site of the STELLAR trial was Karen Fink, MD, PhD, a BSWRI researcher and neuro-oncologist on staff at Baylor University Medical Center. “This is one of the few trials in the country that is looking at grade III tumors instead of grade IV tumors. So, to find enough patients to get a meaningful result, you need to combine forces. This is what we are doing by making sure that any patient with anaplastic astrocytoma within Baylor Scott & White Health has access to the trial.”
Neuro-oncologist Ekokobe Fonkem, DO, who supported the study in Temple, points out additional strengths of expanding clinical trial outreach across these regions of Texas, “We are able to incorporate patients from all demographic and socioeconomic groups. When these patients don’t have to travel, we can reduce costs and increase the time they spend with their families. Plus, the medical records are all connected throughout Baylor Scott & White Health, which is a very powerful research tool. It allows us to look at all the medical history data to study patients appropriately.”
Dr. Fink goes on to add, “One of the reasons why we are able to run these trials is we have a well-tested system for coordinating studies at both locations. We can use the same institutional review board and share data infrastructure for accrual. We also have streamlined a process to minimize costs while maintaining patient safety.”
Looking toward the future, the researchers are working with BSWRI resources to create a system-wide biorepository to collect and store surgical specimens from brain cancer patients. These cancer samples, coupled with blood and other tissue samples, will then be available for researchers to learn about genetic and molecular characteristics of the tumors.
The benefits of evaluating genetic and molecular characteristics of brain tumors were recently clarified in a study led by BSWRI researchers. They used microarray data from glioblastoma samples and identified a four-gene biomarker panel that could be used to predict cancer outcomes. According to Dr. Fonkem, co-author on the work, “We were able to find genetic signatures in saliva and blood, which will help us develop better tests for brain cancer. With better diagnostics, we can potentially help reduce future costs of healthcare and predict how patients will respond to intensive treatment.”