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

Tracking Information
First Submitted Date ICMJE	September 13, 2005
First Posted Date ICMJE	September 21, 2005
Last Update Posted Date	March 5, 2008
Study Start Date ICMJE	May 2001
Actual Primary Completion Date	January 2005 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: September 13, 2005)	To estimate response rates (CR + CCR + PR) according to CD25 status (CD25 positive and negative) after 4 cycles of ONTAK.
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00211198 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: October 2, 2006)	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
Original Secondary Outcome Measures ICMJE; (submitted: September 13, 2005)	1. Physician's Global Assessment (PGA); 2. Time to Event Variables - Time to response, remission, treatment failure; 3. Response based on the CD25 status; 4. Response based on patient demographics: stage of disease, age, sex, performance status, total dose; 5. Number of cycles completed; 6. Assess safety and tolerability of ONTAK
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Study of ONTAK® to Treat Cutaneous T-Cell Lymphoma (CTCL)
Official Title ICMJE	Open Label Study of ONTAK® (Denileukin Diftitox, DAB389IL-2) to Estimate Response in Cutaneous T-Cell Lymphoma (CTCL) According to CD25 Status
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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 4
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Lymphoma, T-Cell, Cutaneous
Intervention ICMJE	Drug: ONTAK (denileukin difitox, DAB389IL-2)
Study Arms	Not Provided
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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Enrollment ICMJE; (submitted: September 13, 2005)	60
Original Enrollment ICMJE	Same as current
Actual Study Completion Date	January 2006
Actual Primary Completion Date	January 2005 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00211198
Other Study ID Numbers ICMJE	#33
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	Eisai Inc.
Collaborators ICMJE	Tufts Medical Center; National Cancer Institute (NCI); Ligand Pharmaceuticals
Investigators ICMJE	Study Chair: Francine Foss, M.D. Yale University
PRS Account	Eisai Inc.
Verification Date	February 2008
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP