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
  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:


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
Investigators
Study Chair: Sam T. Hwang, MD, PhD NCI - Dermatology Branch
  More Information

Additional Information:
Publications:
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 April 22, 2014