Immunization Against Tumor Cells in Sezary Syndrome

Cutaneous T-cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00099593
• Other study ID #: FD-R-002545-01
• Secondary ID: FD-R-002545-01
• Status: Completed
• Phase: Phase 2
• First received: December 17, 2004
• Last updated: March 24, 2015
• Start date: September 2004
• Est. completion date: September 2007

Study information

• Verified date: December 2006
• Source: FDA Office of Orphan Products Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Completion date provided represents the completion date of the grant per OOPD records

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cutaneous T-cell Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous
• Sezary Syndrome
• Syndrome

Intervention

Biological:
• Autologous Dendritic Cell Vaccine

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center, Department of Dermatology	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response (clearance of skin lesions, clinical and radiographic improvement in lymphadenopathy)
Secondary	Biological response
Secondary	Survival
Secondary	Activities of daily living
Secondary	Quality of Life