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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 29, 2014