Immunization Against Tumor Cells in Sezary Syndrome
Immunization Against Tumor Cells in Sezary Syndrome
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.
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
Inclusion Criteria:

 -  Histologically confirmed diagnosis of Sezary syndrome

 -  Must be willing to discontinue concomitant medications for CTCL, including: *Oral
 steroids above 10 mg - 30 day washout, unless subject has Addison's Disease or adrenal
 insufficiency, *PUVA or UVB - 2 week washout, sunbathing, tanning beds, etc. and for
 the duration of the study, *Electron Beam - for the duration of the study,
 *Chemotherapeutic agents - 30 day washout, *Bexarotene capsules or other oral
 biologics - 3 week washout, *Topical nitrogen mustard - 2 week washout,
 *Extracorporeal photopheresis - 4 week washout and for the duration of the study.

 -  Must be at least 18 years of age and must be able to understand the written informed
 consent.

 -  Subjects must have no evidence of active infection. Subjects with active infections
 (whether or not they require antibiotic therapy) may be eligible for continuation of
 therapy after complete resolution of the infection. Subjects on antibiotic therapy
 must be off antibiotics for at least 7 days before beginning treatment.

 Exclusion Criteria:

 -  Subjects with autoimmune disease, HIV, and/or hepatitis

 -  Subjects who are pregnant or lactating