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Analysis of Genes Present in Cutaneous T-Cell Lymphoma Cells

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00020072
First received: July 11, 2001
Last updated: February 6, 2009
Last verified: March 2003
History of Changes

July 11, 2001
February 6, 2009
March 2000
 
 
 
Complete list of historical versions of study NCT00020072 on ClinicalTrials.gov Archive Site
 
 
 
 
 
Analysis of Genes Present in Cutaneous T-Cell Lymphoma Cells
Gene Expression Analysis in Cutaneous T-Cell Lymphoma

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.

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.
Interventional
 
Primary Purpose: Diagnostic
Lymphoma
Other: laboratory biomarker analysis
 
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
 
 
 

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00020072
CDR0000067694, NCI-00-C-0068
 
 
National Cancer Institute (NCI)
 
Study Chair: Sam T. Hwang, MD, PhD NCI - Dermatology Branch
National Cancer Institute (NCI)
March 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP