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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Poly-ICLC is considered an investigational drug and has not been approved by the Food and Drug Administration (FDA) for treatment of your disease. It is currently being tested in clinical trials for brain tumors, lymphoma, human immunodeficiency virus (HIV) and prostate cancer. It is thought that Poly-ICLC, when used with dendritic cells as a vaccine therapy, may work to help the immune system fight disease.
Leukapheresis is a process in which white blood cells are collected from the body. These cells will be given together with Poly-ICLC therapy when subjects begin study treatment.
Medical University of South Carolina
Charleston, South Carolina, United States
Safety
\- safety of this treatment by evaluating the qualitative and quantitative toxicities in this group of patients through adverse event reporting
Time frame: 2 years
Feasibility
\- feasibility of generating dendritic cells and administering these cells as a vaccine to patients
Time frame: 2 years
Anti-tumor Response
anti-tumor response after vaccination, measured by changes in tumor burden and overall survival
Time frame: 2 years
Immunological Responses
\- immunological responses after vaccination (antigen-specific T cell cytokine production, antigen-specific T cell frequencies by tetramer analysis, and DTH reactions)
Time frame: 2 years
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