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Brief Title: Study of Vaccination With Poly-ICLC and Peptide-pulsed Dendritic Cells
Official Title: A Feasibility and Safety Study of Vaccination With Poly-ICLC and Peptide-pulsed Dendritic Cells in Patients With Metastatic and/or Unresectable Melanoma
Study ID: NCT01783431
Brief Summary: This study is for subjects with a type of skin cancer called melanoma. The main purpose of this study is to examine the safety of the study drug (Poly-ICLC) in patients with your disease. The study team would like to know about any side effects a patient may have when given the study drug. Another goal of the study is to determine if combining dendritic cells and the study drug can be possibly used as a vaccine for your disease.
Detailed Description: Dendritic cells are cells that are present in your body's immune system that help your body fight disease. This is a vaccine trial, as your own cells will be extracted (removed), treated in a lab, then re-administered to your body with the study drug in hopes of creating an immune response to the disease. It is not guaranteed that your disease burden will be reduced by participating in this trial.TScreening tests will be conducted to determine whether or not subjects can participate in this study. If subjects are eligible and choose to participate, they will have a procedure called leukapheresis. The leukapheresis product that is collected from you will be taken to a special lab at MUSC where it will undergo a process that will grow additional dendritic cells under controlled conditions in the lab. These cells will be given together with Poly-ICLC therapy when you begin study treatment. Some days you will receive both Poly-ICLC and dendritic cells, but on other days you will receive the Poly-ICLC by itself. After study treatment, subjects may be asked to return to MUSC approximately every 3 months for the first 2 years, then every 6 months thereafter for follow up procedures.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Medical University of South Carolina, Charleston, South Carolina, United States
Name: Keisuke Shirai, MD
Affiliation: Medical University of South Carolina
Role: PRINCIPAL_INVESTIGATOR