Immunization Against Tumor Cells in Sezary Syndrome
Recruitment status was Recruiting
This research is being done to look at the safety and value of a vaccine for a cancer found in the blood and skin known as Cutaneous T-cell lymphoma (CTCL) and Sezary Syndrome.
In the laboratory, researches found that special white blood cells, called dendritic cells (DCs), are able to stimulate the immune system (groups of cells that protect the body from germs and diseases) in a way that helps your body fight cancer. Autologous (from your own body) DCs will be prepared (mixed together) in the laboratory with your cancer cell (Sezary cells) to allow your DCs to pick up parts of your Sezary cells to make the vaccine for you.
Cutaneous T-Cell Lymphoma
Biological: Autologous Dendritic Cell Vaccine
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Evaluation of Immunization Against Tumor Cells in Subjects With Sezary Syndrome Using Autologous Mature Dendritic Cells|
- Clinical response (clearance of skin lesions, clinical and radiographic improvement in lymphadenopathy)
- Biological response
- Activities of daily living
- Quality of Life
|Study Start Date:||September 2004|
|Estimated Study Completion Date:||December 2008|
Although the etiology of CTCL is not completely understood, immunologic factors appear to play an important role.
Dendritic Cell (DC)-tumor cell vaccines have several features that suggest applications for the immunotherapy of human tumors. Importantly, DC-tumor cell immunization has the potential to simultaneously stimulate CD4+ and CD8+ T cell-mediated immunity against multiple tumor antigens.
The vaccine will be prepared from the subject's own blood, obtained during leukapheresis. From leukapheresed blood, monocyte-derived DCs and malignant lymphocytes will be isolated. The DCs will then be loaded with lymphocyte-derived tumor antigens. Formulations and release criteria must be met before vaccine can be administered.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00099593
|Contact: Sue A McCann, MSN, RN, DNC||(412)firstname.lastname@example.org|
|Contact: Rodolfo Chirinos, MD||(412)email@example.com|
|United States, Pennsylvania|
|University of Pittsburgh Medical Center, Department of Dermatology||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15213|
|Contact: Sue A McCann, MSN, RN 412-624-3782 firstname.lastname@example.org|
|Contact: Larisa J Geskin, M.D. (412)648-3161 email@example.com|
|Principal Investigator: Larisa J Geskin, M.D.|
|Sub-Investigator: Louis D Falo, M.D. PhD|
|Sub-Investigator: Kristina Paley, M.D.|
|Sub-Investigator: Sue A McCann, MSN, RN|
|Sub-Investigator: Timothy Patton, O.D.|
|Sub-Investigator: Theresa L Whiteside, PhD|
|Sub-Investigator: Mitchel E Tublin, M.D.|
|Sub-Investigator: Laura Ferris, M.D. PhD|
|Sub-Investigator: Rodolfo Chirinos, M.D.|
|Sub-Investigator: Kenneth Foon, M.D.|
|Sub-Investigator: William Gooding, M.S.|
|Principal Investigator:||Larisa J. Geskin, M.D.||University of Pittsburgh|