Clinical trial NCT00211198: Study of ONTAK® to Treat Cutaneous T-Cell Lymphoma (CTCL)
Official title: Open Label Study of ONTAK® (Denileukin Diftitox, DAB389IL-2) to Estimate Response in Cutaneous T-Cell Lymphoma (CTCL) According to CD25 Status
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lymphoma, T-Cell, Cutaneous
Keywords: Cutaneous
T-cell lymphoma
ONTAK
CD25
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
Collaborators: name: Tufts Medical Center
name: National Cancer Institute (NCI)
name: Ligand Pharmaceuticals
First posted: 2005-09-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: To estimate response rates (CR + CCR + PR) according to CD25 status (CD25 positive and negative) after 4 cycles of ONTAK.
Secondary outcomes:
measure: Physician's Global Assessment (PGA)
measure: Time to Event Variables - Time to response, remission, treatment failure
measure: Response based on the CD25 status
measure: Response based on patient demographics: stage of disease, age, sex, performance status, total dose
measure: Number of cycles completed
measure: 6. Assess safety and tolerability of ONTAK
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Iowa City
country: United States
facility: The University of Iowa
state: Iowa
city: Boston
country: United States
facility: New England Medical Center
state: Massachusetts
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Yale University
name: Francine Foss, M.D.
role: STUDY_CHAIR
References:
citation: 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.