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

Sponsor:	Eisai Inc.
Information provided by:	Eisai Inc.
ClinicalTrials.gov Identifier:	NCT00051012

Purpose

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.

Condition	Intervention	Phase
Lymphoma, T-Cell, Cutaneous Mycosis Fungoides Sezary Syndrome	Drug: ONTAK	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Fungal Infections Lymphoma

Drug Information available for: Denileukin diftitox

U.S. FDA Resources

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:

Objective Rate of Response (ORR), defined as CR + CCR + PR

Secondary Outcome Measures:

Time-to-Treatment Failure
Time-to-Progression
Duration of Response

Estimated Enrollment:	86
Study Start Date:	September 1995
Study Completion Date:	December 2006
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion 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 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.

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00051012

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Locations

United States, Texas
University of Texas, M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Australia, New South Wales
Westmead Hospital, Department of Haematology
Westmead, New South Wales, Australia, 2145
Level 4 Department of Haematology Royal North Shore Hospital
St. Leonard's, New South Wales, Australia, 2065
Australia, Queensland
Mater Misericordiae Adult Hospital
South Brisbane, Queensland, Australia, 4101
Oncology Haematology Radiation Oncology Unit, Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Australia, Victoria
Peter MacCallum Cancer Institute
Melbourne, Victoria, Australia, 3002
Austria
Allgemeines Krankenhaus der Stadt Wien
Vienna, Austria, A-1090
LKH Universitatsklinikum Graz
Graz, Austria, A-8036
Canada, Alberta
Cross Cancer Centre
Edmonton, Alberta, Canada
Canada, Ontario
Hamilton Regional Cancer Center
Hamilton, Ontario, Canada
Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada
Germany
Universitatsklinikum Charite
Berlin, Germany
J.W. Goethe University Frankfurt
Frankfurt, Germany, 60590
Universitatsklinikum Essen
Essen, Germany, 45122
Universitatskrankenhaus Eppendorf
Hamburg, Germany, 20246
Universitatsklinikum Munster
Munster, Germany, D-48149
University of Erlangen
Erlangen, Germany, 91052
Universitatsklinikum Mannheim
Mannheim, Germany, 68135
Poland
Regional Oncological Center, Dept. of Chemotherapy
Lodz, Poland, 93-509
Centrum Onkologii-Instytut im. Marii Sklodoskiej-Curie
Warsaw, Poland, 02-781
Medical Academy in Gdansk, Dept. of Hematology
Gdansk, Poland, 80-952
Klinika Hematoonkologii Akademii Medycznej w Lublinie
Lublin, Poland, 20-950
The Medical University of Warsaw, Central Clinical Hospital
Warsaw, Poland, 02-097
Oddzial Chorob Wewnetrznych i Hematologii
Poznan, Poland, 61-833
Russian Federation
St. Petersburg Pavlov State Medical University
St. Petersburg, Russian Federation
Burdenko Main Military Clinical Hospital
Moscow, Russian Federation
Central Research Institute of Skin and Venereal Diseases
Moscow, Russian Federation
Blokhin Russian Cancer Research Center, RAMS
Moscow, Russian Federation
Haematology Research Center RAMS
Moscow, Russian Federation
Samara Regional Clinical Hospital
Samara, Russian Federation, 443095
Switzerland
Universitatsspital Zurich Dermatologische Klinik
Zurich, Switzerland
United Kingdom
St. John's Institute of Dermatology
London, United Kingdom
City Hospital
Nottingham, United Kingdom
Southampton General Hospital
Southampton, United Kingdom

Sponsors and Collaborators

Eisai Inc.

Investigators

Study Director:

Elyane Lombardy, M.D.

Ligand Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	93-04-14
Study First Received:	December 31, 2002
Last Updated:	February 29, 2008
ClinicalTrials.gov Identifier:	NCT00051012 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Disease
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Sezary Syndrome
Mycosis Fungoides
Pharmacologic Actions
Lymphatic Diseases
Neoplasms

Pathologic Processes
Therapeutic Uses
Denileukin diftitox
Syndrome
Lymphoma, T-Cell
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma
Lymphoma, T-Cell, Cutaneous

ClinicalTrials.gov processed this record on November 27, 2009