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

February 29, 2008 updated by: Eisai Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

86

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Inc.

Investigators

  • Study Director: Elyane Lombardy, M.D., Ligand Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1995

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

December 31, 2002

First Submitted That Met QC Criteria

January 2, 2003

First Posted (Estimate)

January 3, 2003

Study Record Updates

Last Update Posted (Estimate)

March 5, 2008

Last Update Submitted That Met QC Criteria

February 29, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 93-04-14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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