Immunization Against Tumor Cells in Sezary Syndrome

Completed · Phase 2

Conditions studied: Cutaneous T-cell Lymphoma, Sezary Syndrome

In brief

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.

Key facts

Study ID

NCT00099593

Run by

University of Pittsburgh

People needed

17

Starts

2004-09-01

Expected to finish

2007-09-01

Last updated by the study team

2015-03-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

• University of Pittsburgh Medical Center, Department of Dermatology — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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