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

In Vitro Evaluation of Immune Responses in CTCL

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00177190

Enrollment

Registered

2005-09-15

Start date

2002-06-30

Completion date

2006-01-31

Last updated

2014-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cutaneous T-cell Lymphoma, Mycosis Fungoides, Sezary Syndrome

Keywords

Cutaneous T-cell Lymphoma, Sezary Syndrome, Mycosis Fungoides, Immune Responses

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.

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Functional capacity of dendritic cells in-vitro	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

Measure	Time frame	Description
Evaluate antigen loading of dendritic cells	At each cell collection	Functional DCs can be isolated and effectively loaded with the malignant cells by several methods (coculture and fusion)

Countries

United States

Outcome results