Immunization Against Tumor Cells in Sezary Syndrome

NCT00099593 | Completed Phase 2

• 1 other identifier: FD-R-002545-01
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Cutaneous T-cell Lymphoma; Sezary Syndrome

Keywords

Cutaneous T-cell lymphoma (CTCL); Sezary Syndrome; Mycosis Fungoides; Vaccine

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

• Biological response

• Survival

• Activities of daily living

• Quality of Life

Interventions

Autologous Dendritic Cell Vaccine BIOLOGICAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Subjects with autoimmune disease, HIV, and/or hepatitis
• Subjects who are pregnant or lactating

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh Medical Center, Department of Dermatology

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous; Sezary Syndrome; Mycosis Fungoides

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Larisa J. Geskin, M.D.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 17, 2004
• First Posted: December 20, 2004
• Study Start: September 1, 2004
• Study Completion: September 1, 2007
• Last Updated: March 25, 2015

Record last verified: 2006-12

Locations

US (1)