Study of ONTAK (Denileukin Diftitox) in Cutaneous T-Cell Lymphoma (CTCL) Patients

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the effectiveness of two dose levels of ONTAK (denileukin diftitox) in treating patients who have recurrent or persistent cutaneous T-cell lymphoma.

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

Details

• Lead Sponsor: Eisai Inc.
• Treatments: Denileukin diftitox

Criteria

Inclusion Criteria:

• Histopathologically confirmed recurrent or persistent CTCL as determined by reference pathology lab;

• Patient must have had 1 to 3 prior CTCL therapies. Repeated use of the same agent is considered to be 1 therapy unless it is part of a different combination regimen. Only 1 prior combination cytotoxic regimen is permitted. Topical or systemic steroids are not considered a therapy;

• Interleukin-2 receptor (IL-2R) expression on at least 20% of tumor cells as determined by immunohistochemistry.

• Stage IA - III disease and unlikely to progress during the first month on study. Life expectancy of at least 12 months.

• Measurable or evaluable disease. Lymph node involvement no greater than LN2. No CTCL involvement of bone marrow.

• No active CNS disease, kidney or liver disease, significant pulmonary disease, or cardiac disease.

• No systemic infections;

• Willingness to be randomized to a placebo treatment only arm;

• ECOG performance status 0 or 1;

Exclusion Criteria:

• Patients must not have previously received treatment with DAB389IL-2 or DAB486IL 2 (previous candidate compound evaluated in a clinical setting).