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Home > "S" Clinical Trials Conditions > Study of T Cell Genes in Patients with Sezary Syndrome and Mycosis Fungoides  Study of T Cell Genes in Patients with Sezary Syndrome and Mycosis Fungoides
Study of T Cell Genes in Patients with Sezary Syndrome and Mycosis Fungoides
For Condition: Mycosis Fungoides,T Cell Lymphoma,Sezary Syndrome
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study is aimed at learning more about the genetic properties of malignant T cells in mycosis fungoides and Sezary syndrome in order to develop better methods of diagnosing and treating these diseases. The study will use a new technology called the "gene array," or "gene chip," which permits simultaneous analysis of thousands of genes from a single tissue specimen. Mycosis fungoides and Sezary syndrome are two forms of T cell lymphomas-a group of cancers in which malignant cells of the immune system, called T cells, migrate to the skin. In mycosis fungoides, early-stage lesions resemble benign skin conditions such as eczema, often making early diagnosis difficult. Tumors may develop later and internal organs may also be affected. Sezary syndrome-a leukemic form of the lymphoma-is characterized by skin redness and malignant T cells in the blood. Patients 18 years and older with tumor-stage mycosis fungoides or Sezary syndrome may be eligible for this study. All participants will have a medical history and physical examination, including blood tests. Patients with Sezary syndrome will undergo apheresis to collect white blood cells. For this procedure, blood is withdrawn through a needle placed in an arm vein, similar to donating whole blood. The blood then flows into a machine that spins it to separate the different components. The white cells are removed for study, and the red cells are returned to the patient through the same vein. Patients with mycosis fungoides will undergo a skin biopsy. In this procedure, a small portion of a skin lesion (about 1 X 1 1/3 inches) is removed under local anesthesia for examination. A researcher will contact the patient's primary physician every year for up to 5 years to obtain follow-up information on the patient's medical progress.
Details: The cutaneous T cell lymphomas (CTCL) comprise a rare group of non-Hodgkins lymphomas that are characterized by malignant T cells homing to skin. This protocol will study two forms of CTCL: (1) mycosis fungoides (MF) and (2) the leukemic variant known as Sezary syndrome (SS). Early MF resembles, both clinically and histologically, benign dermatoses such as eczema, often making definitive diagnosis difficult. In later stages, tumors may develop and systemic involvement may have fatal consequences. SS patients present with the classic triad of erythroderma, lymphadenopathy, and malignant, clonal T cells in the blood. While diagnosis of CTCL currently relies on distinctive histological features, molecular studies identifying clonality of T cells in skin lesions have also proven useful. Gene array technology makes it possible to study the expression of thousands of genes from a given specimen simultaneously. Our goal is to use gene array technology to study gene expression patterns present in malignant T cell populations derived from individual CTCL patients. Approximately 20 patients with SS and another 20 patients with tumor stage MF will be recruited for this study over the course of two years. SS patients who meet eligibility criteria will be asked to donate 50 ml o fperiphera; blood or undergo mononuclear cell apheresis. Tumor-stage MF patients will have CD4 positive malignant T cells isolated from excisional skin biopsies. In both cases, immunomagnetic beads and/or FACS sorting will be used to isolate the malignant T cell clones. Using gene array technology, RNA from malignant T cells derived from CTCL patients will be compared with RNA from pooled peripheral blood T cells possessing a skin-homing phenotype derived from healthy human blood donors. The benefits of this study will include: (1) defining precise molecular markers for MF that may improve diagnosis and (2) a better understanding of the molecular pathogenesis of CTCL.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Patients must be greater than or equal to 18-85 years of age. MF patients must have two or more plaques or tumors greater than 1 cm in size with histologic confirmation by Dr. Elaine Jaffe at the NIH. SS patients should have erythroderma, lymphadenopathy and TCR V-beta clonality greater than 10% of total lymphocytes by flow cytometry using currently available antibodies or a CD4 positive CD7 negative T cell fraction that represents greater than 10% of CD4 positive T cells. Patients who have received topical therapy within the previous two weeks or other forms of therapy such as systemic chemotherapy, photopheresis, PUVA, UVB or electron beam therapy in the previous two months are not eligible. Patients who have previously tested positive for HIV-1, HTLV-1, or who have a history of intravenous injection drug use are not eligible. Patients must not be pregnant or nursing. Patients must live within the United States or Canada because of limited study funds to provide travel.
Total Enrollment: 40
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 000068; 00-C-0068
Study Start Date: January 28, 2000
Record last reviewed: December 14, 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004546
Other T Cell Lymphoma Studies:
1. Study of T Cell Genes in Patients with Sezary Syndrome and Mycosis Fungoides
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Study of T Cell Genes in Patients with Sezary Syndrome and Mycosis Fungoides
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