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
  Purpose

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 Intervention Phase
Cutaneous T-Cell Lymphoma
Sezary Syndrome
Biological: Autologous Dendritic Cell Vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Evaluation of Immunization Against Tumor Cells in Subjects With Sezary Syndrome Using Autologous Mature Dendritic Cells

Resource links provided by NLM:


Further study details as provided by FDA Office of Orphan Products Development:

Primary Outcome Measures:
  • Clinical response (clearance of skin lesions, clinical and radiographic improvement in lymphadenopathy)

Secondary Outcome Measures:
  • Biological response
  • Survival
  • Activities of daily living
  • Quality of Life

Estimated Enrollment: 17
Study Start Date: September 2004
Estimated Study Completion Date: December 2008
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00099593

Contacts
Contact: Sue A McCann, MSN, RN, DNC (412)624-3782 mccannsa@upmc.edu
Contact: Rodolfo Chirinos, MD (412)624-3782 chirinosr@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center, Department of Dermatology Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Sue A McCann, MSN, RN    412-624-3782    mccannsa@upmc.edu   
Contact: Larisa J Geskin, M.D.    (412)648-3161    geskinlj@msx.upmc.edu   
Principal Investigator: Larisa J Geskin, M.D.         
Sub-Investigator: Louis D Falo, M.D. PhD         
Sub-Investigator: Kristina Paley, M.D.         
Sub-Investigator: Sue A McCann, MSN, RN         
Sub-Investigator: Timothy Patton, O.D.         
Sub-Investigator: Theresa L Whiteside, PhD         
Sub-Investigator: Mitchel E Tublin, M.D.         
Sub-Investigator: Laura Ferris, M.D. PhD         
Sub-Investigator: Rodolfo Chirinos, M.D.         
Sub-Investigator: Kenneth Foon, M.D.         
Sub-Investigator: William Gooding, M.S.         
Sponsors and Collaborators
Investigators
Principal Investigator: Larisa J. Geskin, M.D. University of Pittsburgh
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00099593     History of Changes
Other Study ID Numbers: FD-R-002545-01, FD-R-002545-01
Study First Received: December 17, 2004
Last Updated: September 27, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by FDA Office of Orphan Products Development:
Cutaneous T-cell lymphoma (CTCL)
Sezary Syndrome
Mycosis Fungoides
Vaccine

Additional relevant MeSH terms:
Lymphoma
Syndrome
Lymphoma, T-Cell
Sezary Syndrome
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Disease
Pathologic Processes
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on September 30, 2014