Presently, several clinical Phase III clinical trials are ongoing at the University of Puerto Rico and affiliated Institutions for the treatment of our cancer patients. We are acutely aware of the need for an early clinical trial program at our Institution. The goal of this pilot project is to establish a program of early phase clinical trials at the University of Puerto Rico. To establish this program, we are starting a collaboration with Dr. Daniel Sullivan of the H. Lee Moffitt Cancer Center (HLMCC). This collaboration will emphasize the development of Phase I and Phase III clinical trials, targeting our Puerto Rican population. In addition, we propose to develop basic science infrastructure that will support investigator-initiated studies. Via this collaboration, the HLMCC, will have access to a unique population of patients that have a higher prevalence of specific malignancies in Puerto Rico, such as, esophageal, cervical, penile, anal, breast, and liver cancers. We propose to achieve these goals through the following three specific aims.
In specific aim 1, we will evaluate the facilities of UPR and PRCC to conduct early Phase I and Phase II clinical trials. We will identify the availability of the infrastructure to perform pharmacokinetic, pharmacodynamic, and molecular analyses.
In specific aim 2; we will delineate a plan to establish an early phase clinical trials program within the PRCC. Clinical and basic investigators from the UPR and HLMCC will join efforts in the development of specific clinical trials. Finally, in specific aim 3; we will initiate clinical trials that are based on basic research data.
| Rivera-Peña, Bianca; Ruíz-Fullana, Francisco J; Vélez-Reyes, Germán L et al. (2016) HPV-16 infection modifies overall survival of Puerto Rican HNSCC patients. Infect Agent Cancer 11:47 |
| Baez, Adriana; Cantor, Alan; Fonseca, Sharon et al. (2005) Differences in Smad4 expression in human papillomavirus type 16-positive and human papillomavirus type 16-negative head and neck squamous cell carcinoma. Clin Cancer Res 11:3191-7 |
