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

• Physician's Global Assessment (PGA)
• Time to Event Variables - Time to response, remission, treatment failure
• Response based on the CD25 status
• Response based on patient demographics: stage of disease, age, sex, performance status, total dose
• Number of cycles completed
• 6. Assess safety and tolerability of ONTAK

• 1. Physician's Global Assessment (PGA)
• 2. Time to Event Variables - Time to response, remission, treatment failure
• 3. Response based on the CD25 status
• 4. Response based on patient demographics: stage of disease, age, sex, performance status, total dose
• 5. Number of cycles completed
• 6. Assess safety and tolerability of ONTAK

The purpose of this research study is to evaluate how effective ONTAK is in the treatment of cutaneous T-cell Lymphoma (CTCL) and determine whether the presence of a type of protein called CD25 on the cancer cells makes a difference in how the body responds to the treatment.

The hypothesis is that there is no difference in response rate for patients whose tumor cells are CD25 positive or negative.

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.

• Tufts Medical Center
• National Cancer Institute (NCI)
• Ligand Pharmaceuticals