In Vitro Evaluation of Immune Responses in Cutaneous T-Cell Lymphoma (CTCL)
|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: NCT00177190|
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : May 28, 2014
|Condition or disease|
|Cutaneous T-cell Lymphoma Sezary Syndrome Mycosis Fungoides|
This is an in vitro evaluation of cutaneous T-cell lymphoma using patients blood and tissue to evaluate immune responses related to identified tumor populations and dendritic/ CD 8 cells with the following objectives:
- Objective I: Evaluate the feasibility of the preparation of dendritic cells (DCs), CD8 and Sezary cells (all CD4 positive) in vitro, obtained from the buffy coats or a skin biopsy from an area with tumor involvement of subjects with cutaneous t-cell lymphoma (CTCL) and Sezary syndrome (leukemic stage of CTCL) undergoing an approved FDA therapy, extracorporeal photopheresis (ECP).
- Objective II: Evaluate antigen loading of the DCs.
- Objective III: Test the functional capacities of the DCs derived from CTCL subjects to overcome immune tolerance to the tumor cells ex-vivo, by using modified Elispot assay in conjunction with Granzyme B Elispot assay as a measurement of cytotoxicity.
|Study Type :||Observational|
|Actual Enrollment :||8 participants|
|Official Title:||In Vitro Evaluation of Immune Responses in CTCL|
|Study Start Date :||June 2002|
|Actual Primary Completion Date :||January 2005|
|Actual Study Completion Date :||January 2006|
- Functional capacity of dendritic cells in-vitro [ Time Frame: At each cell collection ]Evaluate the feasibility of the preparation of dendritic cells (DCs), CD8 and Sezary cells (all CD4 positive) in vitro, obtained from the buffy coats or a skin biopsy from an area with tumor involvement of subjects with cutaneous t-cell lymphoma (CTCL) and Sezary syndrome (leukemic stage of CTCL)
- Evaluate antigen loading of dendritic cells [ Time Frame: At each cell collection ]Functional DCs can be isolated and effectively loaded with the malignant cells by several methods (coculture and fusion)
Biospecimen Retention: Samples Without DNA
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): NCT00177190
|United States, Pennsylvania|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Larisa J. Geskin, M.D.||University of Pittsburgh|