Immunization Against Tumor Cells in Sezary Syndrome
Recruitment status was Recruiting
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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 |
- Clinical response (clearance of skin lesions, clinical and radiographic improvement in lymphadenopathy)
- Biological response
- Survival
- Activities of daily living
- Quality of Life
| Estimated Enrollment: | 17 |
| Study Start Date: | September 2004 |
| Estimated Study Completion Date: | December 2008 |
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 |
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| 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, 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. | |
| 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 Sezary Syndrome Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin |
ClinicalTrials.gov processed this record on May 19, 2013