Open label study of ONTAK (denileukin diftitox) in previously treated Cutaneous T-cell Lymphoma patients.

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 CTCL patients whose tumors do not express CD25.

Official Title

A multicenter open-label study to evaluate the safety and efficacy of DAB389IL-2 in cutaneous T-cell lymphoma (CTCL) patients following Protocol 93-04-10, Protocol 93-04-11, or Protocol 92-04-01 or who meet the requirements for Protocol 93-04-11 except have biopsy-documented CTCL that does not express CD25

Conditions

– Lymphoma, T-Cell, Cutaneous- Mycosis Fungoides- Sezary Syndrome

Study Type

Interventional

Study Design

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Further Details

Genders Eligible for Study: Both 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 measureable 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.

Study Start

Eligibility & Criteria

Total Enrolment

86

Contact Details

[1] Peter MacCallum Cancer Institute, Melbourne, Australia; Recruiting [2] Ligand Pharmaceuticals