Study of Vaccination With Poly-ICLC and Peptide-pulsed Dendritic Cells
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01783431|
Recruitment Status : Terminated (The study was terminated early due to low accrual.)
First Posted : February 4, 2013
Last Update Posted : October 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Drug: Poly ICLC Procedure: leukapheresis||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||October 2012|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||November 2013|
Experimental: Leukapheresis and Poly-ICLC
Screening 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.
Drug: Poly ICLC
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.
- Safety [ Time Frame: 2 years ]- safety of this treatment by evaluating the qualitative and quantitative toxicities in this group of patients through adverse event reporting
- Feasibility [ Time Frame: 2 years ]- feasibility of generating dendritic cells and administering these cells as a vaccine to patients
- Anti-tumor Response [ Time Frame: 2 years ]anti-tumor response after vaccination, measured by changes in tumor burden and overall survival
- Immunological Responses [ Time Frame: 2 years ]- immunological responses after vaccination (antigen-specific T cell cytokine production, antigen-specific T cell frequencies by tetramer analysis, and DTH reactions)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01783431
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||Keisuke Shirai, MD||Medical University of South Carolina|