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

History of Changes

Tracking Information

First Received Date ^ICMJE

December 17, 2004

Last Updated Date

September 27, 2007

Start Date ^ICMJE

September 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Clinical response (clearance of skin lesions, clinical and radiographic improvement in lymphadenopathy)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00099593 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Biological response
Survival
Activities of daily living
Quality of Life

Original Secondary Outcome Measures ^ICMJE

Biological response
Survival
Activities of daily living

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Immunization Against Tumor Cells in Sezary Syndrome

Official Title ^ICMJE

Phase II Evaluation of Immunization Against Tumor Cells in Subjects With Sezary Syndrome Using Autologous Mature Dendritic Cells

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Cutaneous T-Cell Lymphoma
Sezary Syndrome

Intervention ^ICMJE

Biological: Autologous Dendritic Cell Vaccine

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2008

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00099593

Other Study ID Numbers ^ICMJE

FD-R-002545-01, FD-R-002545-01

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

FDA Office of Orphan Products Development

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Larisa J. Geskin, M.D.

University of Pittsburgh

Information Provided By

FDA Office of Orphan Products Development

Verification Date

December 2006

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

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