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
- Histopathologically confirmed recurrent or persistent CTCL as determined by reference
- 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
- No systemic infections;
- Willingness to be randomized to a placebo treatment only arm;
- ECOG performance status 0 or 1;
• Patients must not have previously received treatment with DAB389IL-2 or DAB486IL 2
(previous candidate compound evaluated in a clinical setting).