Protocol Number: 04-C-0081

Title:

Pathogenesis and Course of Cutaneous T-Cell Lymphoma

Number:

04-C-0081

Summary:

This study will follow the course of patients with cutaneous T-cell lymphomas (including mycosis fungoides or Sezary syndrome) to learn more about the disease and to screen patients for possible enrollment in clinical treatment trials. Cutaneous T-cell lymphomas are a group of rare, poorly characterized cancers of specific white blood cells that develop in skin. Their appearance on the skin various considerably, ranging from areas of dry-appearing skin to thicker areas, or even redness over the entire body. The cause of the disease is not known.

Patients 18 years of age and older with cutaneous T-cell lymphoma may be eligible for this study. Candidates will be screened with an analysis of previous skin or lymph node specimens and skin biopsies. Participants will undergo the following tests and procedures:

-Medical history and physical examination

-Blood tests

-Skin lesion biopsy: For the biopsy, a small area of skin is numbed with a local anesthetic and a 1/4-inch piece of skin is removed with a cookie cutter-like instrument.

-Photographs of skin at the first and subsequent visits to record changes. Infrared photos may also be obtained to analyze the extent of skin disease.

-Bone marrow aspirate and biopsy, if necessary, to assess the extent of disease. For the bone marrow biopsy, the skin over the hipbone and the outer surface of the hipbone itself are numbed with local anesthesia. A small needle is used to inject the anesthetic. Then, a larger needle is inserted into the hipbone and about 1 tablespoon of bone marrow is drawn into a syringe. Another needle is inserted into the same area to collect a small piece of the bone marrow.

-Imaging studies such as CT scans or ultrasound, if necessary, to assess the extent of disease. For the CT scan, the patient lies on a table that slides into the doughnut-shaped scanner. For the ultrasound, a probe that emits sound waves is placed over the area to be examined to obtain images.

Participants will have follow-up evaluations yearly or more frequently, depending on the extent and course of disease, indefinitely. These visits will include skin and lymph node examinations, full-body photographic documentation of skin disease, blood tests, and, if needed, skin biopsies, bone marrow biopsy, and x-ray studies.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): Children

Eligibility Criteria:

INCLUSION CRITERIA:

1. Patients must have one of the following:

A. Cutaneous T-cell lymphoma (mycosis fungoides or Sezary syndrome) stage IA to IVB confirmed by clinical and histologic examination.

B. Other primary or secondary cutaneous T-cell lymphoma confirmed by clinical and histologic examination.

C. A pre-CTCL skin condition, including large plaque parapsoriasis and lymphomatoid papulosis, confirmed by clinical and histologic examination.

2. Patients must have disease that is measurable by assessment of skin lesions or quantification of Sezary cell count.

3. Patients must be referred from practitioner who will continue their care/evaluation in tandem with the protocol.

4. Patients must be able to give written informed consent.

5. Patients are eligible regardless of prior therapy for their disease.

EXCLUSION CRITERIA:

1. HTLV-I/II serologic positivity.

Special Instructions:

Currently Not Provided

Keywords:

Mycosis Fungoides

Sezary Syndrome

Non-Hodgkins Lymphoma

Parapsoriasis

Lymphomatoid Papulosis

Recruitment Keyword(s):

Cutaneous T Cell Lymphoma

Mycosis Fungoides

Sezary Syndrome

Condition(s):

Cutaneous T-Cell Lymphoma

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Cancer Institute

Contact(s):

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
Phone: 1-888-NCI-1937
Fax: Not Listed
Electronic Address: ncicssc@mail.nih.gov

Citation(s):

Akpek G, Koh HK, Bogen S, O'Hara C, Foss FM. Chemotherapy with etoposide, vincristine, doxorubicin, bolus cyclophosphamide, and oral prednisone in patients with refractory cutaneous T-cell lymphoma. Cancer. 1999 Oct 1;86(7):1368-76.

Diamandidou E, Colome M, Fayad L, Duvic M, Kurzrock R. Prognostic factor analysis in mycosis fungoides/Sezary syndrome. J Am Acad Dermatol. 1999 Jun;40(6 Pt 1):914-24.

Diamandidou E, Cohen PR, Kurzrock R. Mycosis fungoides and Sezary syndrome. Blood. 1996 Oct 1;88(7):2385-409. Review. No abstract available.

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