For Angel Rivera and Amanda Ralabate, both Clinical Research Nurses for the Melanoma and Renal Cell Carcinoma disease teams within the Yale Cancer Center Clinical Trials Office, collaboration and communication are key. They work under the leadership of Drs. Mario Sznol and Harriet Kluger and are involved with the implementation and carrying out of clinical trials.
Recently they assisted with implementing and successfully executing a novel melanoma treatment that required both in-patient and ambulatory treatments.
This cutting-edge Phase I/II clinical trial evaluates the use of T cell therapy to treat malignant melanoma. The first patient enrolled at Yale was only the second patient to be enrolled in the United States. The protocol involves taking T-cells from the patient, genetically modifying them to express a high affinity T-cell receptor specific for a specific type of protein on the patient's tumor, and then re-infusing these T cells back into the patient to target his or her cancer.
"The actual treatment involves in-patient chemotherapy to prepare the patient's immune system for the subsequent T cell re-infusion that is administered in the out-patient setting However, the work that goes on behind the scenes to get to that point is immense," Angel said.
As clinical research nurses, Angel and Amanda are responsible for ensuring the accuracy of the research data that is sent to, and reviewed by, the FDA as part of the drug approval process. "Excellent communication between our team of physician investigators, the APRN sub-investigator, clinical nurses, Research Pharmacists, CTO staff, sponsors, monitors, and regulatory agencies is essential for protocol compliance and the generation of quality data. The integrity of the data is so important as it will effect drug approval for future commercial use," Amanda said.
Both Angel and Amanda find their current positions rewarding; it combines their love of science with patient care. Knowing that they are part of cutting-edge, clinical research that may change the way patients with melanoma and renal cell carcinomas are treated is why they both became clinical research nurses.
Kathleen Reed, RN, MS, AOCNS, Nurse Manager for the Clinical Trials Office commented, "As novice clinical research nurses, Angel and Amanda have done an outstanding job contributing to the successful execution of ground breaking clinical trials for melanoma and renal cell carcinoma. Their efforts, and the efforts of all members of their interdisciplinary team, support the ultimate goal of providing access to personalized cancer medicine and help get us 'closer to free!'"