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

Completed · Phase 4

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

In brief

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.

Key facts

Study ID

NCT00051012

Run by

Eisai Inc.

People needed

86

Starts

1995-09-01

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…

• 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.

You may not qualify if…

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

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
• Peter MacCallum Cancer Institute — Melbourne, Victoria, 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
• 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
• Blokhin Russian Cancer Research Center, RAMS — Moscow, Russia

Full record on ClinicalTrials.gov

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