Analysis of Genes Present in Cutaneous T-cell Lymphoma Cells

NCT ID: NCT00020072

Last Updated: 2015-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-03-31

Brief Summary

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.

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.

Conditions

Lymphoma

Study Design

• Primary Study Purpose: DIAGNOSTIC

Interventions

laboratory biomarker analysis

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Principal Investigators

Sam T. Hwang, MD, PhD

Role: STUDY_CHAIR

NCI - Dermatology Branch

Locations

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, United States

Countries

United States

References

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. doi: 10.1046/j.1523-1747.2001.01282.x.

Reference Type: RESULT

PMID: 11231324 (View on PubMed)

Other Identifiers

NCI-00-C-0068

Identifier Type: -

Identifier Source: secondary_id

CDR0000067694

Identifier Type: -

Identifier Source: org_study_id

NCT00004546

Identifier Type: -

Identifier Source: nct_alias