Glioblastoma multiforme, the most aggressive form of brain tumor, is a devastating and deadly disease. However, a drug to control these tumors is now completing worldwide Phase III clinical trials. The drug, Cilengitide, may offer hope to those with glioblastoma, and it was early clinical work conducted at UAB’s Clinical Research Unit—part of the CCTS—that helped move the drug to this phase.
“We were the lead institution in the development of a novel drug, Cilengitide, for brain cancer patients,” says Dr. Burt Nabors, Director of the Division of Neuro-Oncology and director of the CCTS’ Clinical Research Unit (CRU).
The concept behind the CRU is that it participates in study development, implementation, and outreach, and is sustainable through a comprehensive cost-recovery mechanism. The CRU includes: Nursing, Bionutrition (Metabolic Kitchen), and the Clinical Research Support Program (CRSP), and it works closely with the Child Health Research Unit (a partnership with The Children’s Hospital of Alabama). In January 2009, the CRU outpatient facility relocated to the 15th floor of Jefferson Tower (JT 15) with inpatient accommodations on 8 MEB. In April 2010 the Metabolic Kitchen moved into its renovated space on JT 15. Since transitioning from the General Clinical Research Center to the CCTS in 2008, the CRU has provided services for nearly 266 studies serving the needs of over 800 investigators. Studies comprise specialties in anesthesiology, epidemiology, exercise physiology, dentistry, genetics, nutrition, psychiatry, in addition to multiple areas within internal medicine and surgery.
Nabors, who has been treating patients and conducting research on brain tumors at UAB since 1995, became director of the CRU shortly after the CCTS was funded in 2008. He says all elements of the CRU combine to strive for one goal: “to simplify the process of utilization for research investigators.” This includes, for example, reducing the number of application pages to gain access to the CRU from 14 to 4, with additional cuts on the way.
Another goal, Nabors says, is to “expand the number of square feet available for research, and to enhance the space we already have. This will allow us to be more attractive to industry-sponsored research, and to have the room and the facilities to give FDA-approved experimental therapies.”
Nabors himself has used the CRU to conduct his own clinical research.
Nabors highlights the work currently being done in the CRU’s Bionutrition Core, in the Metabolic Kitchen. “We are conducting research in the areas of diet and nutrition for diabetes, cancer, and obesity—an area of potential high return regionally.”
Nabors says he recognizes the trouble that investigators, faculty, and staff sometimes have in understanding all the services the CCTS offers. He explains it as being “structured to help provide the acceleration of clinical research, training, pilot grants, informatics and statistical support; and to promote interactions with the community as a whole. The CRU is no longer the central focus, rather it is much broader. Our goal is to move it beyond the physical space. We have had increasing degrees of institutional support and partnerships. Now we would like to increase utilization of our services, both by researchers and trial participants. We want to make it easier for the patient to volunteer, and to reward their contribution. At the same time, we recognize that not every bit of research should be done here, so we hope to reach out via the Clinical Research Support Program and other CCTS services.”
One project the CRU is currently engaged in, Nabors says, is the development of a Phase I Clinical Trials Unit in conjunction with the Comprehensive Cancer Center. Construction of the Unit has already begun and the first phase will be complete by October, allowing the CCTS to provide increased support for clinical trials.
“These types of partnerships can result in work that is transformational,” he says. Nabors is currently involved in a nutrition study in brain cancer patients that utilizes the Bionutrition and the Biomedical Informatics (BMI) resources of the CRU, looking at energy expenditure in brain cancer patients and how that may be affected by the cancer or the treatment of the cancer.
“In addition,” Nabors says, “we are looking at the microbiome in these patients and how it may be impacted by the same issues. I use the CRU for most of our clinical research. It assists us with patient infusions of experimental therapy, the collection of specimens from patients, and the processing of samples.”
Nabors’ research has been funded in part by a Drug Discovery pilot grant, sponsored by the CCTS and the Alabama Drug Discovery Alliance (ADDA). The grants can be used for any aspect of drug discovery and development for any human disease. The idea behind the grants is to take UAB’s most promising basic science discoveries and facilitate their translation to targets for drug discovery that will improve human health and clinical research.