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Study of ONTAK (Denileukin Diftitox) in Cutaneous T-Cell Lymphoma (CTCL) Patients
This study has been completed.
First Received: December 31, 2002   Last Updated: February 29, 2008   History of Changes
Sponsor: Eisai Inc.
Information provided by: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00050999
  Purpose

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.


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

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Multicenter Phase III Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy of Two Dose Levels of DAB389IL-2 (9 and 18 Mcg/kg/Day) in Cutaneous T-Cell Lymphoma (CTCL) Patients With Stage Ia-III Disease Who, Following Less Than or Equal to 3 Previous Therapies, Have Recurrent or Persistent Disease That Has Been Biopsy-Documented to Express CD25

Resource links provided by NLM:


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: 195
Study Start Date: June 1995
Study Completion Date: December 2006
Primary Completion Date: September 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:

  • 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;

Exclusion Criteria:

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00050999

  Hide Study Locations
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
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
University of Erlangen
Erlangen, Germany, 91052
Universitatsklinikum Mannheim
Mannheim, Germany, 68135
Universitatsklinikum Munster
Munster, Germany, D-48149
Universitatsklinikum Essen
Essen, Germany, 45122
Universitatskrankenhaus Eppendorf
Hamburg, Germany, 20246
Sektion Dermatologische Onkologie
Tubingen, Germany, D-72076
Netherlands
LUMC, Department of Dermatology
Leiden, Netherlands, 2333 ZA
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: 93-04-11
Study First Received: December 31, 2002
Last Updated: February 29, 2008
ClinicalTrials.gov Identifier: NCT00050999     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