Study of ONTAK® to Treat Cutaneous T-Cell Lymphoma (CTCL)

Inclusion Criteria: Persistent or recurrent cutaneous T-cell lymphoma (CTCL) Stage IB-IVA as defined by TNM staging. Pathologic proven diagnosis (cytologically confirmed) of CTCL documented in patient history. Preserved organ function: Creatinine and/or Liver Function levels <1.5 times institutional upper limits of normal (ULN). Adequate liver function as indicated by bilirubin < or equal to 1.5 times ULN, ALT < or equal to 2 times ULN, AST < or equal to 2 times ULN. Albumin >3.0 g/dL Adequate renal function as indicated by SCr < or equal to 2.5 mg/dl. ECOG performance status between 0-2. Women of childbearing potential should be screened for pregnancy prior to treatment and utilize effective contraceptive methods (e.g. barrier) during treatment period. Patients over the age of 18 who are willing and able to provide Informed Consent. Exclusion Criteria: Pathology consistent with peripheral T-cell lymphoma. Stage IVB (visceral involvement with CTCL, other than lymph node involvement). History of Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C infection. Patients who are pregnant or breast feeding. Allergy to or have history of allergy to diphtheria toxin or IL-2. Previous ONTAK® usage. Unstable cardiovascular disease. Patients who have received systemic or topical antineoplastic therapy or investigational medications within past 14 days. Exception: Clear evidence of disease progression requiring immediate intervention and in the absence of ongoing toxicity from prior therapy. Ongoing deep vein thrombosis or a diagnosis of deep vein thrombosis less than 3 months prior to protocol enrollment.