Expired Study
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Bethesda, Maryland 20892


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.


Study summary:

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.


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


NCT ID:

NCT00020072


Primary Contact:

Study Chair
Sam T. Hwang, MD, PhD
NCI - Dermatology Branch


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 20, 2017

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