Immunization Against Tumor Cells in Sezary Syndrome

Cutaneous T-cell Lymphoma Clinical Trial

Official title: Phase II Evaluation of Immunization Against Tumor Cells in Subjects With Sezary Syndrome Using Autologous Mature Dendritic Cells

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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.

Completion date provided represents the completion date of the grant per OOPD records ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cutaneous T-cell Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous
• Sezary Syndrome
• Syndrome

• NCT number: NCT00099593
• Study type: Interventional
• Source: FDA Office of Orphan Products Development
• Status: Completed
• Phase: Phase 2
• Start date: September 2004
• Completion date: September 2007