A Phase II Clinical Trial of Anti-Tac(Fv)-PE38 (LMB-2) Immunotoxin for Treatment of CD25 Positive Cutaneous T-Cell Lymphomas

Date de début de l'étude : 30 avril 2004

* INCLUSION CRITERIA: Patients must have histopathological evidence of cluster of differentiation 25 (CD25) + cutaneous T-cell lymphoma (CTCL) confirmed by the National Institutes of Health (NIH) pathology department. One of the following must be present: Greater than or equal to 20 percent expression of CD25 on the lymphocytes in the skin at a site of a patch, plaque, or tumor. Greater than or equal to 20 percent of the peripheral blood Sezary cells must be CD25+. Measurable stage Ib-IV disease that has progressed after at least 2 prior systemic or topical therapies. Patients must have a Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2 and be at least 18 years old. Patients must be able to understand and give informed consent. Patients must be 4 weeks from any monoclonal antibodies. Patients must be greater than or equal to 3 weeks from any CTCL-specific therapy and have evidence of progressive disease. Patients who are on chronic steroids must be on a stable dose of Prednisone less than or equal to 20 mg/day (or equivalent dose of another steroid) for at least 3 weeks and have evidence of progressive disease. Female patients of childbearing potential must have a negative pregnancy test and must use effective contraception (a barrier form of contraception). The transaminases alanine aminotransferase (ALT) and aspartate aminotransferase (AST) must each be less than or equal to 2.5-times the upper limits of normal. Albumin must be greater than or equal to 3.0 gm/dL. Total bilirubin must be less than or equal to 2.2 mg/dL. The creatinine must be less than or equal to 2.0 mg/dL or the creatinine clearance must be greater than or equal to 50 ml/min. The absolute neutrophil count (ANC) must be greater than or equal to 1000/mm\^3 and the unsupported platelet count must be greater than or equal to 50,000/mm\^3 in patients without blood or bone marrow involvement. If there is blood or bone marrow involvement, the ANC must be greater than or equal to 500 mm\^3 and the platelets must be greater than or equal to 10,000/mm\^3. The cardiac ejection fraction as assessed by echocardiogram or nuclear medicine study must not be less than the institutional limit of normal. Pulmonary function studies must demonstrate a carbon monoxide diffusing capacity (DLCO) greater than or equal to 55 percent and a forced expiratory volume 1 (FEV1) greater than or equal to 60 percent of normal for inclusion. EXCLUSION CRITERIA: Patients whose serum neutralizes LMB-2 in tissue culture, due either to anti-toxin or anti-mouse-IgG antibodies. No patient whose serum neutralizes greater than 75 percent of the activity of 1 microg/mL of LMB-2 will be treated. Patients who are pregnant or breast-feeding. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Patients who are human immunodeficiency virus (HIV) positive, hepatitis B antigen positive, hepatitis C polymerase chain reaction (PCR) positive, or who have other chronic liver disease. Patients with symptomatic cardiac or pulmonary disease. Patients on warfarin therapy. Such patients may be eligible if they can be switched to heparin or low-molecular weight heparin therapy and are off warfarin at least 4 days prior to study enrollment. Active cancer requiring treatment.