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

Open Label Study of ONTAK® (Denileukin Diftitox, DAB389IL-2) to Estimate Response in Cutaneous T-Cell Lymphoma (CTCL) According to CD25 Status

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.

Study Overview

• Status: Completed
• Conditions: Lymphoma, T-Cell, Cutaneous
• Intervention / Treatment: Drug: ONTAK (denileukin difitox, DAB389IL-2)

• Study Type: Interventional
• Enrollment: 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope National Medical Center
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University School of Medicine
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • The University of Iowa
  • Massachusetts
    • Boston, Massachusetts, United States
      • New England Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals of Cleveland
    • Columbus, Ohio, United States, 43210
      • Ohio State University
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University
  • Texas
    • Houston, Texas, United States, 77030-4009
      • The University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

• Sponsor: Eisai Inc.
• Collaborators: National Cancer Institute (NCI); Tufts Medical Center; Ligand Pharmaceuticals
• Investigators: Study Chair: Francine Foss, M.D., Yale University

Publications and helpful links

General Publications

• Francine Foss, Madeleine Duvic, Larisa Geskin, Joseph Anderson, Pierluigi Porcu, Raymond J. Hohl, Maureen Cooper, Jasmine M. Zain, John Zic, Patrica Hibberd, and Mark Acosta Efficacy and Safety of Denileukin Diftitox (Ontak®) in the Treatment of Cutaneous T-Cell Lymphoma (CTCL) According to CD25 Status. Blood (ASH Annual Meeting Abstracts), Nov 2006; 108: 2712.

Study record dates

Study Major Dates

• Study Start: May 1, 2001
• Primary Completion (Actual): January 1, 2005
• Study Completion (Actual): January 1, 2006

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 21, 2005

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

• Keywords: T-cell lymphoma; CD25; Cutaneous; ONTAK
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, T-Cell, Cutaneous; Antineoplastic Agents; Denileukin diftitox
• Other Study ID Numbers: #33