Study of ONTAK (Denileukin Diftitox) in Previously Treated Cutaneous T-Cell Lymphoma 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:	NCT00051012

Purpose

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.

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

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer 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:	86
Study Start Date:	September 1995
Study Completion Date:	December 2006
Primary Completion Date:	October 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:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00051012

Show 34 Study Locations

Sponsors and Collaborators

Eisai Inc.

Investigators

Study Director:

Elyane Lombardy, M.D.

Ligand Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	93-04-14
Study First Received:	December 31, 2002
Last Updated:	February 29, 2008
ClinicalTrials.gov Identifier:	NCT00051012 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