Analysis of Genes Present in Cutaneous T-Cell Lymphoma Cells - Full Text View

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00020072

Purpose

RATIONALE: Analyzing genes that are present in cancer cells may be useful in developing better methods to detect, predict, and treat cutaneous T-cell lymphoma.

PURPOSE: Clinical trial to study genes that are present in cutaneous T-cell lymphoma cells.

Condition	Intervention
Lymphoma	Other: laboratory biomarker analysis

Study Type:	Interventional
Study Design:	Primary Purpose: Diagnostic
Official Title:	Gene Expression Analysis in Cutaneous T-Cell Lymphoma

Resource links provided by NLM:

Genetics Home Reference related topics: Help Me Understand Genetics

MedlinePlus related topics: Cancer Lymphoma

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

March 2000

Detailed Description:

OBJECTIVES:

Identify gene expression patterns in malignant T cells that can be used to diagnose cutaneous T-cell lymphoma.
Determine the patterns of gene expression that distinguish normal skin-homing T cells from malignant T cells.

OUTLINE: Patients are stratified by disease (Sezary syndrome vs mycosis fungoides) and prior treatment (yes vs no).

All patients receive a physical examination, and a medical history is taken. Patients with Sezary syndrome undergo leukapheresis. Patients with plaque/tumor stage mycosis fungoides undergo skin biopsy of involved skin. Malignant T cells from blood or skin are then isolated and patterns of gene expression in the malignant T cells are compared to those in normal skin-homing T cells from healthy donors using a "gene chip" (Lymphochip).

Patients are followed annually for 5 years.

PROJECTED ACCRUAL: A total of 40 patients (20 per disease stratum) will be accrued for this study within 2 years.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically proven mycosis fungoides with 2 or more plaques or tumors greater than 1 cm in size OR
Immunologically proven Sezary syndrome with all of the following:
- Erythroderma
- Lymphadenopathy
- T-cell receptor variable beta chain clonality greater than 10% of total lymphocytes by flow cytometry OR
- CD4+CD7- T-cell fraction that represents greater than 10% of CD4+ T cells

PATIENT CHARACTERISTICS:

Age:

18 to 85

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

See Disease Characteristics

Hepatic:

Not specified

Renal:

Not specified

Other:

Not pregnant or nursing
HIV-1 and HTLV-1 negative
No prior intravenous drug use

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

At least 2 months since prior systemic chemotherapy

Endocrine therapy:

Not specified

Radiotherapy:

At least 2 months since prior electron beam radiotherapy

Surgery:

Not specified

Other:

At least 2 weeks since prior topical therapy
At least 2 months since prior photopheresis
At least 2 months since prior psoralen ultraviolet light (PUVA) or ultraviolet B (UVB) therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00020072

Locations

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair:

Sam T. Hwang, MD, PhD

NCI - Dermatology Branch

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Hwang ST, Fitzhugh DJ. Aberrant expression of adhesion molecules by Sezary cells: functional consequences under physiologic shear stress conditions. J Invest Dermatol. 2001 Mar;116(3):466-70.

ClinicalTrials.gov Identifier:	NCT00020072 History of Changes
Obsolete Identifiers:	NCT00004546
Other Study ID Numbers:	CDR0000067694, NCI-00-C-0068
Study First Received:	July 11, 2001
Last Updated:	February 6, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

cutaneous T-cell non-Hodgkin lymphoma
mycosis fungoides/Sezary syndrome

Additional relevant MeSH terms:

Lymphoma
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 February 12, 2012