Gene Expression Analysis in Cutaneous T-Cell Lymphoma
18 Years
85 Years
Both
Lymphoma
Trial Information
Gene Expression Analysis in Cutaneous T-Cell Lymphoma
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Diagnostic
Principal Investigator
Sam T. Hwang, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
NCI - Dermatology Branch
Authority:
United States: Federal Government
Study ID:
CDR0000067694
NCT ID:
NCT00020072
Start Date:
March 2000
Completion Date:
Related Keywords:
- Lymphoma
- cutaneous T-cell non-Hodgkin lymphoma
- mycosis fungoides/Sezary syndrome
- Lymphoma
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Cutaneous
Name | Location |
|---|---|
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | Bethesda, Maryland 20892-1182 |
