A Review of Dendritic Cell Vaccines in Cancer Treatment and a Managerial Focus on Issues Related to Subject Recruitment

McFarlin, Tory. A Review of Dendritic Cell Vaccines in Cancer Treatment and a Managerial Focus on Issues Related to Subject Recruitment. Master of Science (Clinical Research Management), December 2006, 97 pp., 5 tables, bibliography, 24 titles. Melanoma is form of skin cancer that can become deadly if the cancer progresses to a stage of metastasis. Five year survival rates as low as 10% may be noted in such patients. Decarbazine and Proleukin have been approved by the FDA for the treatment of metastatic melanoma; however both have response rates of approximately 20% or less. New treatment modalities including dendritic cell (DC) vaccines are currently being tested for treating metastatic melanoma with greater safety and efficacy profiles. DC vaccines are made by obtaining a subject’s DCs, priming them with melanoma antigen ex vivo and then injecting them into the patient to initiate an immune response against melanoma tumor cells in vivo. Investigational new treatments such has the DC vaccine must first be tested in clinical trials on research subjects. Subject enrollment issues regarding such a trial can cause delays in advances of the treatment. As an intern with a DC vaccine clinical trial, the author assisted in screening 45 patients and observed many hindrances involving enrollment of subjects. Such hindrances include: low rates of study personnel retention, small patient pools, and competing trials. Recommendations to improve enrollment include: more effective advertisement strategies and increased patient education.