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

Lymphoma, T-Cell, Cutaneous Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00211198
• Other study ID #: #33
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: February 29, 2008
• Start date: May 2001
• Est. completion date: January 2006

Study information

• Verified date: February 2008
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Other known NCT identifiers

• NCT00279396

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2006
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous

Intervention

Drug:
• ONTAK (denileukin difitox, DAB389IL-2)

Locations

Country	Name	City	State
United States	New England Medical Center	Boston	Massachusetts
United States	University Hospitals of Cleveland	Cleveland	Ohio
United States	Ohio State University	Columbus	Ohio
United States	City of Hope National Medical Center	Duarte	California
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas
United States	The University of Iowa	Iowa City	Iowa
United States	Vanderbilt University	Nashville	Tennessee
United States	Yale University School of Medicine	New Haven	Connecticut
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
Eisai Inc.	Ligand Pharmaceuticals, National Cancer Institute (NCI), Tufts Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To estimate response rates (CR + CCR + PR) according to CD25 status (CD25 positive and negative) after 4 cycles of ONTAK.
Secondary	Physician's Global Assessment (PGA)
Secondary	Time to Event Variables - Time to response, remission, treatment failure
Secondary	Response based on the CD25 status
Secondary	Response based on patient demographics: stage of disease, age, sex, performance status, total dose
Secondary	Number of cycles completed
Secondary	6. Assess safety and tolerability of ONTAK