Chrystal Paulos, PhD & Ragini Kudchadkar, MD

Though survival for patients with advanced melanoma has improved over the last decade with the introduction of anti-PD-1 antibodies, half of patients treated with this therapy have disease that recurs. Both combination immunotherapies and single-agent anti-PD-1 antibodies are currently used to treat melanoma. However, combination therapies have higher responses but also higher toxicity rates. Currently, there are no definitive biomarkers that can predict which therapy choice is correct for metastatic melanoma patients.  

This project is focused on understanding why patients are resistant to PD1-based therapies.  We recently discovered that patients with more CD26 (a type of protein) found in the tumor’s immune cells are more responsive to treatment. These collective findings beg the question: What is the role of CD26 in the immune response to melanoma?  

To answer this question we will study CD26 melanoma immunity using melanoma patients’ blood and tumor samples.  This data will allow CD26 to be used as a biomarker in prognosis for patients treated with PD-1-based therapies, and allow for future studies for clinicians to use CD26 as a predictive biomarker to help select the appropriate treatment for a patient, i.e., combination or single-agent immunotherapy. 

The role of CD26 activity in melanoma immune response will be defined by this project. Findings from this research will be the basis for future clinical trials to target CD26 in order to enhance immunity against tumors that are unresponsive to PD-1-based therapy in order to create new hope for patients with PD-1-refractory melanoma. 

Manali Bhave, MD

Funded by Hooters of America, LLC

There have been significant advances in the treatment of patients living with metastatic breast cancer. Some of these advances are due to a fairly new type of technology looking at changes in the DNA of the tumor (somatic next-generation sequencing (NGS)) and/or in patient’s normal cells (germline NGS) that may impact a patient’s prognosis and/or treatment options, including the opportunity to enroll on clinical trials.

Very few studies have looked at patient understanding and knowledge on this type of advanced testing (next-generation sequencing), though of the studies available, there appears to be a low level of patient knowledge on next-generation sequencing and a gap in expectations as to how this form of testing can impact a patient’s clinical care.

The aim of our study is to increase the enrollment of patients with metastatic breast cancer into clinical trials that match patients to specific therapies based on their NGS through 1) increasing patient knowledge and understanding of NGS and 2) using the education tool to identify the change in the rate of NGS testing, as well as change of treatment recommendations based on these results. 


Tobey MacDonald, MD

Funded by the Buster and Kristen Posey Fund

Brain tumors cause the most cancer deaths in children. A tumor known as medulloblastoma (MB) is the most common type of childhood brain cancer. Children die of MB because the cancer spreads through the brain. New information indicates that some MB cells may first go into the bloodstream before spreading to the brain and forming new tumors. Cancer cells in the bloodstream are called “circulating tumor cells” (CTCs). We recently developed a tool called Cluster-Chip that can detect CTCs in the blood and remove them so that they can be studied. Using our Cluster-Chip tool, we want to see how often CTCs are found in the blood, and in which MB patients we find them in. Next, we want to see exactly what CTCs look like, what they are made of, and if they are different from the rest of the brain tumor. Finally, we want to see whether the number, the appearance or the make-up of CTCs in the blood can tell us if the tumor will go on to spread to the brain and if the patient will die of their disease. We will study 25 patients with MB and collect their blood at different times throughout their treatment. This information will help us to understand how MB cancer spreads and how to better treat MB tumor spread.

Manali Bhave, M.D.

Funded by Hooters of America, LLC

Immunotherapy is a new treatment that uses certain parts of a person’s immune system to fight cancer. It is now used in combination with chemotherapy to treat a specific group of women with triple negative breast cancer who have disease that has spread to multiple parts of their bodies and who are not candidates for surgery.

Very few African American women were enrolled on clinical trials of immunotherapy. Therefore, we do not know if immunotherapy will have the same results in African American women as it does in Caucasian women.

The aim of our study is to increase awareness and education in African American women on the use of immunotherapy in breast cancer and to increase enrollment of African American women in a specific clinical trial which will open at the Winship Cancer Institute and Grady Memorial Hospital studying the combination of radiation and immunotherapy in women with triple negative breast cancer. We will accomplish this through a social media campaign on Facebook, Twitter and Instagram, patient educational pamphlets throughout Winship Cancer Institute and Grady Memorial Hospital and the support of an African American clinical research coordinator.

Through our program, we hope to increase the enrollment of African American women onto our immunotherapy clinical trial and answer important questions about the use of immunotherapy in African American women. If successful, the content we develop will set the stage for other educational material aimed at increasing African Americans enrollment on trials of immunotherapy regardless of disease site.

Jim Zhong, M.D.

Funded by Hooters of America, LLC

Minority patients are often underrepresented in clinical trials, data from which we derive our standard of care. Due to the underrepresentation of these patients, the clinical outcomes of treatments may be inappropriately extrapolated for these patients. Barriers to participation for minority patients include unconscious bias by medical practitioners, patient distrust of the medical enterprise, as well as language and medical literacy deficits. Ideally, clinical trials should aim for enrollment of ethnic composition that mirrors the proportion of patients affected by a particular cancer stage.

To address these deficits to equitable trial enrollment, we propose a supplementation of the traditional consent process to be tailored for the purposes of increasing minority enrollment. To this end, we propose to use video-based education tools using virtual-reality technology and to enhance our patient navigator program to increase minority recruitment an ongoing breast clinical trial. The use of virtual-reality videos will allow patients to see the environment in which they would receive treatment to reduce anxiety with an otherwise unfamiliar treatment such as radiation therapy.

We propose to employ the above recruitment strategies in an ongoing Phase I/II clinical trial aimed at investigating the safety and efficacy of concurrent cyclin-dependent kinase (CDK) 4/6 inhibitors with radiosurgery in women with advanced hormone receptor positive breast cancers with brain metastases. The goals of this study are to (1) improve minority clinical trial participation and to (2) improve the optimal communication strategies specific to this population that can be employed to help increase minority clinical trial enrollment.

Preeti Subhedar, M.D.

Funded by Hooters of America, LLC

Significant progress in the field of breast oncology has been made with information gathered from clinical trials. Minority patients account for less than 10% of clinical trial participants. African American and Hispanic American patients only comprised 10% and 5%, respectively, of all participants in the ACOSOG Z0011 trial for early breast cancer. Barriers to participation of minority patients include; the lack of awareness of clinical trials, an unwillingness to participate, and the need for a more labor intensive approach to enrollment. Recruitment strategies to increase minority patient enrollment include involving families and patient navigators for outreach and education, utilizing internet resources, and making physicians more aware about the up to date clinical trials available at their institution. The AVON Comprehensive Breast Center at Grady Memorial Hospital is a safety net hospital that primarily serves an urban, inner city population, where 85% of patients are African American. The goal of this study is to (1) identify the potential motivators and barriers of African American patients towards clinical trial participation at an urban hospital and to (2) identify the optimal communication strategy specific to this population, that can be employed to help increase minority clinical trial enrollment. 

Lauren McCullough, Ph.D.

Funded by Hooters of America, LLC

Breast cancer is the most common cancer diagnosed among US women. The discovery and treatment of breast cancers has improved, but survival differences continue. African-American women have greater deaths across all types of breast cancer. While many social, economic, lifestyle, and biologic factors contribute to survival differences, we believe that fat and its impact on the cancer environment is an important factor. More African-American women are obese than Whites, and obesity has been linked to increased odds of breast cancer occurring again, spreading to other locations, and death. In older women (>50 years), most of the hormones that drive breast cancer are from total body fat. But, certain changes specific to breast fat may influence breast cancer. Early data show that one of these changes may be the development of crown-like structures (CLS). CLS of the breast (CLS-B) has been linked to greater inflammation, hormones, and poor survival among White women. We believe that CLS-B are more common in African-American than White women across body size, and that they are related to worse survival leading to the observed differences by race. This award would support the first study of obesity, CLS-B presence, and related outcomes in group of African-American and similar White women being treated for breast cancer (400 women total). Our study will advance the understanding of obesity and the breast cancer environment, as well as explain the value of CLS-B as a predictor of treatment response, breast cancer outcomes, and possible driver of differences among African-American women.

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