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

• Status: Completed
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eisai Inc.
• Collaborators: Ligand Pharmaceuticals; National Cancer Institute (NCI); Tufts Medical Center
• Treatments: Denileukin diftitox

Criteria

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.