In Vitro Evaluation of Immune Responses in Cutaneous T-Cell Lymphoma (CTCL) - Full Text View

Sponsored by:	University of Pittsburgh
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00177190

Purpose

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.

Condition
Cutaneous T-Cell Lymphoma Sezary Syndrome Mycosis Fungoides

MedlinePlus related topics: Fungal Infections Lymphoma

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	In Vitro Evaluation of Immune Responses in CTCL

Further study details as provided by University of Pittsburgh:

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

White cells

Enrollment:	8
Study Start Date:	June 2002
Study Completion Date:	January 2006

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Cutaneous Lymphoma Clinic patients

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00177190

Locations

United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

University of Pittsburgh

Investigators

Principal Investigator:

Larisa J. Geskin, M.D.

University of Pittsburgh

More Information

Responsible Party:	University of Pittsburgh Medical Center ( Larisa Geskin, MD )
Study ID Numbers:	0307015
Study First Received:	September 12, 2005
Last Updated:	June 4, 2008
ClinicalTrials.gov Identifier:	NCT00177190
Health Authority:	United States: Institutional Review Board; United States: Institutional Review Board

Keywords provided by University of Pittsburgh:

Cutaneous T-cell Lymphoma
Sezary Syndrome
Mycosis Fungoides
Immune Responses

Study placed in the following topic categories:

Lymphatic Diseases
Mycoses
Sezary syndrome
Immunoproliferative Disorders
Cutaneous T-cell lymphoma
Lymphoma, T-Cell

Sezary Syndrome
Mycosis Fungoides
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Lymphoma, T-Cell, Cutaneous

Additional relevant MeSH terms:

Neoplasms
Pathologic Processes
Disease

Neoplasms by Histologic Type
Immune System Diseases
Syndrome

ClinicalTrials.gov processed this record on January 16, 2009