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

February 29, 2008 updated by: Eisai Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Drug: ONTAK

Study Type

Interventional

Enrollment

195

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
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
    - Universitätsklinikum 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
  - Tubingen, Germany, D-72076
    - Sektion Dermatologische Onkologie
Netherlands
- - Leiden, Netherlands, 2333 ZA
    - LUMC, Department of Dermatology
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
    - UniversitätsSpital Zürich 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

Genders Eligible for Study

All

Description

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).

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: Randomized
Interventional Model: Parallel Assignment
Masking: Double

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

June 1, 1995

Primary Completion (Actual)

September 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

93-04-11

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.