A Feasibility and Safety Study of Vaccination With Poly-ICLC and Peptide-pulsed Dendritic Cells in Patients With Metastatic and/or Unresectable Melanoma
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
- safety of this treatment by evaluating the qualitative and quantitative toxicities in this group of patients through adverse event reporting
Keisuke Shirai, MD
Medical University of South Carolina
United States: Food and Drug Administration
|Medical University of South Carolina||Charleston, South Carolina 29425-0721|