Open Label Study of ONTAK® (Denileukin Diftitox, DAB389IL-2) to Estimate Response in Cutaneous T-Cell Lymphoma (CTCL) According to CD25 Status

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.