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

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ClinicalTrials.gov Identifier: NCT00177190
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : May 28, 2014
Sponsor:
Information provided by (Responsible Party):
Larisa Geskin, University of Pittsburgh

Brief Summary:
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 or disease
Cutaneous T-cell Lymphoma Sezary Syndrome Mycosis Fungoides

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.

Study Type : Observational
Actual Enrollment : 8 participants
Time Perspective: Prospective
Official Title: In Vitro Evaluation of Immune Responses in CTCL
Study Start Date : June 2002
Primary Completion Date : January 2005
Study Completion Date : January 2006





Primary Outcome Measures :
  1. Functional capacity of dendritic cells in-vitro [ Time Frame: At each cell collection ]
    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)


Secondary Outcome Measures :
  1. Evaluate antigen loading of dendritic cells [ Time Frame: At each cell collection ]
    Functional DCs can be isolated and effectively loaded with the malignant cells by several methods (coculture and fusion)


Biospecimen Retention:   Samples Without DNA
White cells


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Larisa Geskin, Associate Professor of Dermatology, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00177190     History of Changes
Other Study ID Numbers: 0307015
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: May 28, 2014
Last Verified: June 2013

Keywords provided by Larisa Geskin, University of Pittsburgh:
Cutaneous T-cell Lymphoma
Sezary Syndrome
Mycosis Fungoides
Immune Responses

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Mycoses
Mycosis Fungoides
Sezary Syndrome
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin