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
1 other identifier
interventional
60
1 country
9
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started May 2001
Longer than P75 for phase_4
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2006
CompletedMarch 5, 2008
February 1, 2008
3.7 years
September 13, 2005
February 29, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To estimate response rates (CR + CCR + PR) according to CD25 status (CD25 positive and negative) after 4 cycles of ONTAK.
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Inc.lead
- Tufts Medical Centercollaborator
- National Cancer Institute (NCI)collaborator
- Ligand Pharmaceuticalscollaborator
Study Sites (9)
City of Hope National Medical Center
Duarte, California, 91010, United States
Yale University School of Medicine
New Haven, Connecticut, 06520, United States
The University of Iowa
Iowa City, Iowa, 52242, United States
New England Medical Center
Boston, Massachusetts, United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106, United States
Ohio State University
Columbus, Ohio, 43210, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Vanderbilt University
Nashville, Tennessee, 37232, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030-4009, United States
Related 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.
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Francine Foss, M.D.
Yale University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 21, 2005
Study Start
May 1, 2001
Primary Completion
January 1, 2005
Study Completion
January 1, 2006
Last Updated
March 5, 2008
Record last verified: 2008-02