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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Larisa Geskin, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00177190
First received: September 12, 2005
Last updated: May 27, 2014
Last verified: June 2013
  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:

Primary Outcome Measures:
  • Functional capacity of dendritic cells in-vitro [ Time Frame: At each cell collection ] [ Designated as safety issue: No ]
    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:
  • Evaluate antigen loading of dendritic cells [ Time Frame: At each cell collection ] [ Designated as safety issue: No ]
    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


Enrollment: 8
Study Start Date: June 2002
Study Completion Date: January 2006
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Associate Professor of Dermatology, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00177190     History of Changes
Other Study ID Numbers: 0307015
Study First Received: September 12, 2005
Last Updated: May 27, 2014
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
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Mycoses
Mycosis Fungoides
Sezary Syndrome
Syndrome
Disease
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014