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

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

Summary

The purpose of this study is to provide an opportunity for patients who exhibit progressive disease while receiving placebo on the companion 93-04-11 study to receive ONTAK. It is also designed to determine the effectiveness of ONTAK in Cutaneous T-cell Lymphoma (CTCL) patients whose tumors do not express CD25.

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

Details

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

Criteria

Inclusion Criteria:

• Patient must have been previously enrolled in Protocol 93-04-11 and randomized to the placebo arm; or the patient met all eligibility criteria for protocol 93-04-11 other than the expression of CD25 on CTCL tumor cells.

• CTCL disease Stage Ia - III.

• History of less than or equal to 3 previous 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 chemotherapy regimen is permitted. Topical or systemic steroids are not considered a therapy.

• Patient must have evaluable or measurable disease. Lymph node involvement no greater than LN2. No CTCL involvement of bone marrow.

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

• No systemic infections.

• ECOG performance status of 0 or 1.

Exclusion Criteria:

• The 93-04-14 study is no longer open to subjects previously enrolled in 93-04-10 or 92-04-01.