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:

MedlinePlus related topics: 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:	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

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 09, 2009