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Investigator(s):
Robert J. Kreitman, M.D. Principal Investigator Phone: 301-496-6947 kreitmar@mail.nih.gov
Referral Contact(s):
Linda Ellison, R.N. Research Nurse Phone: 301-496-9458 Fax: 240-220-7677 ellisonl@mail.nih.gov	Rita Mincemoyer, R.N. Research Nurse Phone: 301-594-1778 Fax: 240-220-7677 mincemor@mail.nih.gov	Elizabeth Maestri, R.N. Research Nurse Phone: 301-402-5633 Fax: 240-220-7677 maestrie@mail.nih.gov

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Primary Eligibility:

• Histologically confirmed cutaneous T-cell lymphoma (CTCL)
• Stage IB-IV disease
• CD25-positive disease meeting at least 1 of the following criteria:
• At least 20% expression of CD25 on the lymphocytes in the skin at a site of a patch, plaque, or tumor
• At least 20% of the peripheral blood Sézary cells must be CD25-positive
• Disease progression after at least 2 prior systemic or topical therapies
• Measurable disease

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Treatment Plan:

• Patients receive LMB-2 immunotoxin IV over 30 minutes on days 1, 3, and 5
• Treatment repeats every 28 days for up to 6 courses in the absence of disease progression, unacceptable toxicity, or neutralizing antibodies
• Patients receive up to 2 additional courses after achieving a complete remission
• Patients are followed after completing protocol treatment

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 6/18/08
Updated: 5/23/07