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
- 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
- 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.
- Subjects with autoimmune disease, HIV, and/or hepatitis
- Subjects who are pregnant or lactating