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

This study has been completed.
Sponsor:
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00050999
First received: December 31, 2002
Last updated: February 29, 2008
Last verified: February 2008
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

  Show 35 Study Locations
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Elyane Lombardy, M.D. Ligand Pharmaceuticals
  More Information

No publications provided by Eisai Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00050999     History of Changes
Obsolete Identifiers: NCT00002683
Other Study ID Numbers: 93-04-11
Study First Received: December 31, 2002
Last Updated: February 29, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lymphoma
Mycoses
Mycosis Fungoides
Sezary Syndrome
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Denileukin diftitox
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014