In Vitro Evaluation of Immune Responses in CTCL
18 Years
N/A
Both
Cutaneous T-Cell Lymphoma, Sezary Syndrome, Mycosis Fungoides
Trial Information
In Vitro Evaluation of Immune Responses in CTCL
This is an in vitro evaluation of cutaneous T-cell lymphoma using patients blood and tissue
to evaluate immune responses related to identified tumor populations and dendritic/ CD 8
cells with the following objectives:
- Objective I: Evaluate the feasibility of the preparation of dendritic cells (DCs), CD8
and Sezary cells (all CD4 positive) in vitro, obtained from the buffy coats or a skin
biopsy from an area with tumor involvement of subjects with cutaneous t-cell lymphoma
(CTCL) and Sezary syndrome (leukemic stage of CTCL) undergoing an approved FDA therapy,
extracorporeal photopheresis (ECP).
- Objective II: Evaluate antigen loading of the DCs.
- Objective III: Test the functional capacities of the DCs derived from CTCL subjects to
overcome immune tolerance to the tumor cells ex-vivo, by using modified Elispot assay
in conjunction with Granzyme B Elispot assay as a measurement of cytotoxicity.
Inclusion Criteria:
- Males or females <18 years of age
- Histologically confirmed stage IV cutaneous T-cell lymphoma, with at least 5% of the
peripheral blood lymphocytes showing atypical morphology consistent with Sezary cells
- Ambulatory and be in stable medical condition
- Biopsy positive mycosis fungoides/CTCL or clonal type of CTCL as determined by PCR
for TCR and Southern blot for TCR
Exclusion Criteria:
- Received any chemotherapy or radiotherapy within 4 weeks prior to enrollment
- Significant psychiatric illness which would prevent adequate informed consent in the
opinion of the principal investigator
- Systemic steroid therapy other than maintenance for adrenal suppression
- Known coagulopathy for non SS subjects.
Type of Study:
Observational
Study Design:
Time Perspective: Prospective
Principal Investigator
Larisa J. Geskin, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Pittsburgh
Authority:
United States: Institutional Review Board
Study ID:
0307015
NCT ID:
NCT00177190
Start Date:
June 2002
Completion Date:
January 2006
Related Keywords:
- Cutaneous T-cell Lymphoma
- Sezary Syndrome
- Mycosis Fungoides
- Cutaneous T-cell Lymphoma
- Sezary Syndrome
- Mycosis Fungoides
- Immune Responses
- Lymphoma
- Mycoses
- Mycosis Fungoides
- Sezary Syndrome
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Cutaneous
Name | Location |
|---|---|
| University of Pittsburgh Medical Center | Pittsburgh, Pennsylvania 15213 |
