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.
- 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
- No systemic infections.
- ECOG performance status of 0 or 1.
• The 93-04-14 study is no longer open to subjects previously enrolled in 93-04-10 or