Study of ONTAK® to Treat Cutaneous T-Cell Lymphoma (CTCL)

This study has been completed.
Sponsor:
Collaborators:
Tufts Medical Center
Ligand Pharmaceuticals
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00211198
First received: September 13, 2005
Last updated: February 29, 2008
Last verified: February 2008
  Purpose

The purpose of this research study is to evaluate how effective ONTAK is in the treatment of cutaneous T-cell Lymphoma (CTCL) and determine whether the presence of a type of protein called CD25 on the cancer cells makes a difference in how the body responds to the treatment.

The hypothesis is that there is no difference in response rate for patients whose tumor cells are CD25 positive or negative.


Condition Intervention Phase
Lymphoma, T-Cell, Cutaneous
Drug: ONTAK (denileukin difitox, DAB389IL-2)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label Study of ONTAK® (Denileukin Diftitox, DAB389IL-2) to Estimate Response in Cutaneous T-Cell Lymphoma (CTCL) According to CD25 Status

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • To estimate response rates (CR + CCR + PR) according to CD25 status (CD25 positive and negative) after 4 cycles of ONTAK.

Secondary Outcome Measures:
  • Physician's Global Assessment (PGA)
  • Time to Event Variables - Time to response, remission, treatment failure
  • Response based on the CD25 status
  • Response based on patient demographics: stage of disease, age, sex, performance status, total dose
  • Number of cycles completed
  • 6. Assess safety and tolerability of ONTAK

Estimated Enrollment: 60
Study Start Date: May 2001
Study Completion Date: January 2006
Primary Completion Date: January 2005 (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:

  • Persistent or recurrent cutaneous T-cell lymphoma (CTCL) Stage IB-IVA as defined by TNM staging.
  • Pathologic proven diagnosis (cytologically confirmed) of CTCL documented in patient history.
  • Preserved organ function: Creatinine and/or Liver Function levels <1.5 times institutional upper limits of normal (ULN).
  • Adequate liver function as indicated by bilirubin < or equal to 1.5 times ULN, ALT < or equal to 2 times ULN, AST < or equal to 2 times ULN.
  • Albumin >3.0 g/dL
  • Adequate renal function as indicated by SCr < or equal to 2.5 mg/dl.
  • ECOG performance status between 0-2.
  • Women of childbearing potential should be screened for pregnancy prior to treatment and utilize effective contraceptive methods (e.g. barrier) during treatment period.
  • Patients over the age of 18 who are willing and able to provide Informed Consent.

Exclusion Criteria:

  • Pathology consistent with peripheral T-cell lymphoma.
  • Stage IVB (visceral involvement with CTCL, other than lymph node involvement).
  • History of Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C infection.
  • Patients who are pregnant or breast feeding.
  • Allergy to or have history of allergy to diphtheria toxin or IL-2.
  • Previous ONTAK® usage.
  • Unstable cardiovascular disease.
  • Patients who have received systemic or topical antineoplastic therapy or investigational medications within past 14 days. Exception: Clear evidence of disease progression requiring immediate intervention and in the absence of ongoing toxicity from prior therapy.
  • Ongoing deep vein thrombosis or a diagnosis of deep vein thrombosis less than 3 months prior to protocol enrollment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00211198

Locations
United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
United States, Iowa
The University of Iowa
Iowa City, Iowa, United States, 52242
United States, Massachusetts
New England Medical Center
Boston, Massachusetts, United States
United States, Ohio
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
United States, Texas
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
Eisai Inc.
Tufts Medical Center
Ligand Pharmaceuticals
Investigators
Study Chair: Francine Foss, M.D. Yale University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00211198     History of Changes
Obsolete Identifiers: NCT00279396
Other Study ID Numbers: #33
Study First Received: September 13, 2005
Last Updated: February 29, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Eisai Inc.:
Cutaneous
T-cell lymphoma
ONTAK
CD25

Additional relevant MeSH terms:
Lymphoma
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