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

Mycosis Fungoides Clinical Trial

Official title:

In Vitro Evaluation of Immune Responses in CTCL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00177190
• Other study ID #: 0307015
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: May 27, 2014
• Start date: June 2002
• Est. completion date: January 2006

Study information

• Verified date: June 2013
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: January 2006
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Cutaneous T-cell Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous
• Mycosis Fungoides
• Sezary Syndrome

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional capacity of dendritic cells in-vitro	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)	At each cell collection	No
Secondary	Evaluate antigen loading of dendritic cells	Functional DCs can be isolated and effectively loaded with the malignant cells by several methods (coculture and fusion)	At each cell collection	No