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

Completed · Phase 4

Conditions studied: Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides, Sezary Syndrome

In brief

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.

Key facts

Study ID

NCT00050999

Run by

Eisai Inc.

People needed

195

Starts

1995-06-01

Expected to finish

2006-12-01

Last updated by the study team

2008-03-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;

You may not qualify if…

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

Where it is running

• University of Texas, M.D. Anderson Cancer Center — Houston, Texas, United States
• Level 4 Department of Haematology Royal North Shore Hospital — Saint Leonard's, New South Wales, Australia
• Westmead Hospital, Department of Haematology — Westmead, New South Wales, Australia
• Mater Misericordiae Adult Hospital — South Brisbane, Queensland, Australia
• Oncology Haematology Radiation Oncology Unit, Princess Alexandra Hospital — Woolloongabba, Queensland, Australia
• LKH Universitatsklinikum Graz — Graz, Austria
• Allgemeines Krankenhaus der Stadt Wien — Vienna, Austria
• Cross Cancer Centre — Edmonton, Alberta, Canada
• Hamilton Regional Cancer Center — Hamilton, Ontario, Canada
• Jewish General Hospital — Montreal, Quebec, Canada
• Universitatsklinikum Charite — Berlin, Germany
• University of Erlangen — Erlangen, Germany
• Universitatsklinikum Essen — Essen, Germany
• J.W. Goethe University Frankfurt — Frankfurt, Germany
• Universitatskrankenhaus Eppendorf — Hamburg, Germany
• Universitatsklinikum Mannheim — Mannheim, Germany
• Universitatsklinikum Munster — Münster, Germany
• Sektion Dermatologische Onkologie — Tübingen, Germany
• LUMC, Department of Dermatology — Leiden, Netherlands
• Medical Academy in Gdansk, Dept. of Hematology — Gdansk, Poland
• Regional Oncological Center, Dept. of Chemotherapy — Lodz, Poland
• Klinika Hematoonkologii Akademii Medycznej w Lublinie — Lublin, Poland
• Oddzial Chorob Wewnetrznych i Hematologii — Poznan, Poland
• The Medical University of Warsaw, Central Clinical Hospital — Warsaw, Poland
• Centrum Onkologii-Instytut im. Marii Sklodoskiej-Curie — Warsaw, Poland

Full record on ClinicalTrials.gov

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