Immunization Against Tumor Cells in Sezary Syndrome
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|ClinicalTrials.gov Identifier: NCT00099593|
Recruitment Status : Completed
First Posted : December 20, 2004
Last Update Posted : March 25, 2015
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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.
|Condition or disease||Intervention/treatment||Phase|
|Cutaneous T-cell Lymphoma Sezary Syndrome||Biological: Autologous Dendritic Cell Vaccine||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Evaluation of Immunization Against Tumor Cells in Subjects With Sezary Syndrome Using Autologous Mature Dendritic Cells|
|Study Start Date :||September 2004|
|Actual Study Completion Date :||September 2007|
- Clinical response (clearance of skin lesions, clinical and radiographic improvement in lymphadenopathy)
- Biological response
- Activities of daily living
- Quality of Life
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- Subjects with autoimmune disease, HIV, and/or hepatitis
- Subjects who are pregnant or lactating
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00099593
|United States, Pennsylvania|
|University of Pittsburgh Medical Center, Department of Dermatology|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Larisa J. Geskin, M.D.||University of Pittsburgh|
|Other Study ID Numbers:||
|First Posted:||December 20, 2004 Key Record Dates|
|Last Update Posted:||March 25, 2015|
|Last Verified:||December 2006|
Cutaneous T-cell lymphoma (CTCL)
Lymphoma, T-Cell, Peripheral
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Immune System Diseases