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Gene Expression Analysis in Cutaneous T-Cell Lymphoma


N/A
18 Years
85 Years
Not Enrolling
Both
Lymphoma

Thank you

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 SupportBethesda, Maryland  20892-1182