Immunization Against Tumor Cells in Sezary Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by FDA Office of Orphan Products Development.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00099593
First received: December 17, 2004
Last updated: September 27, 2007
Last verified: December 2006

December 17, 2004
September 27, 2007
September 2004
Not Provided
Clinical response (clearance of skin lesions, clinical and radiographic improvement in lymphadenopathy)
Same as current
Complete list of historical versions of study NCT00099593 on ClinicalTrials.gov Archive Site
  • Biological response
  • Survival
  • Activities of daily living
  • Quality of Life
  • Biological response
  • Survival
  • Activities of daily living
Not Provided
Not Provided
 
Immunization Against Tumor Cells in Sezary Syndrome
Phase II Evaluation of Immunization Against Tumor Cells in Subjects With Sezary Syndrome Using Autologous Mature Dendritic Cells

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cutaneous T-Cell Lymphoma
  • Sezary Syndrome
Biological: Autologous Dendritic Cell Vaccine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
17
December 2008
Not Provided

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
Both
18 Years and older
No
Contact: Sue A McCann, MSN, RN, DNC (412)624-3782 mccannsa@upmc.edu
Contact: Rodolfo Chirinos, MD (412)624-3782 chirinosr@upmc.edu
United States
 
NCT00099593
FD-R-002545-01, FD-R-002545-01
Not Provided
Not Provided
FDA Office of Orphan Products Development
Not Provided
Principal Investigator: Larisa J. Geskin, M.D. University of Pittsburgh
FDA Office of Orphan Products Development
December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP