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

This study has been completed.
Sponsor:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00177190
First received: September 12, 2005
Last updated: January 12, 2010
Last verified: January 2010
  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

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

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Biospecimen Retention:   Samples Without DNA

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

No publications provided

Responsible Party: Larisa Geskin, MD, University of Pittsburgh Medical Center
ClinicalTrials.gov Identifier: NCT00177190     History of Changes
Other Study ID Numbers: 0307015
Study First Received: September 12, 2005
Last Updated: January 12, 2010
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Lymphoma
Mycoses
Mycosis Fungoides
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 April 15, 2014