As Professor and Chair of Radiation Medicine at MUSC and Medical Director of the Hollings Cancer Center (HCC) Clinical Trials Office (CTO), I have extensive experience in all phases of clinical trial development and management. Working closely with the Administrative Director of the HCC CTO, I am a strong advocate to assure HCC has the resources needed to develop IIT and manage clinical trials with proper regulatory oversight. I have designed, conducted, completed, and published multiple clinical trials over my 18+ years at MUSC. I have been an active member of our local IRB for over a decade; I have reviewed hundreds of studies and have a thorough understanding of the processes of opening new studies and conducting them in an ethical manner within regulatory guidelines and with appropriate oversight. As contact-PI for our NCORP-MU grant, I am part of a team that strives to bring clinical trials to patients at community sites many miles from any major cancer center.
GU and GI cancers are the majority of my practice and have been for more than 20 years. I have written, conducted, and published multiple clinical trials in prostate and GI cancers. Furthermore, I have worked for years with the NCI cooperative group system and currently serve on the NCI GU Steering Committee.
My research efforts have focused on the development of clinical trials that test novel approaches to treating cancer patients. One example is our investigation of the role of vitamin D in GI and GU cancers. Working both with patients in the clinic and through collaborations with co-investigators in the laboratory, we have shown that vitamin D may play an important role in progression of prostate cancer, prostate cancer racial disparities, and modulation of resistance to treatment in colorectal cancer. Our initial single-arm vitamin D supplementation protocol for men with low-risk prostate cancer showed that vitamin D supplementation of 4000 IU orally was safe and without any significant toxicity. Furthermore, preliminary findings suggest that it may decrease cancer progression to clinically significant disease. This study resulted in a VA-funded randomized clinical trial that has completed accrual and is in follow-up status. Our studies suggest that vitamin D deficiency may influence the well-documented racial disparity in prostate cancer outcomes. African Americans in our study had more vitamin D deficiencies at initiation of the study and vitamin D supplementation was able to eliminate that deficiency within 8 weeks. We are very interested to see how vitamin D supplementation for one year affects outcomes in the recently completed randomized trial with regards to race and initial vitamin D levels. My work with collaborators in colorectal cancer has also demonstrated that vitamin D can enhance sensitivity of tumor cells to radiation and that sensitivity may be reduced by Slug expression.
In addition to the role of Vitamin D in cancer, I have collaborated with many other researchers in Hollings, MUSC, and nationwide, including clinicians and bench scientists, to investigate pathways and treatment paradigms that may be influenced by radiotherapy. I have also worked with multiple tumor study groups to develop and complete multimodality early stage clinical trials, such as in locally-advanced pancreatic cancer and high-risk prostate cancer.