Status:
COMPLETED
Study of ONTAK® to Treat Cutaneous T-Cell Lymphoma (CTCL)
Lead Sponsor:
Eisai Inc.
Collaborating Sponsors:
Tufts Medical Center
National Cancer Institute (NCI)
Conditions:
Lymphoma, T-Cell, Cutaneous
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2001
Trial Type :
INTERVENTIONAL
End Date :
January 1 2006
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00211198
Start Date
May 1 2001
End Date
January 1 2006
Last Update
March 5 2008
Active Locations (9)
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1
City of Hope National Medical Center
Duarte, California, United States, 91010
2
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
3
The University of Iowa
Iowa City, Iowa, United States, 52242
4
New England Medical Center
Boston, Massachusetts, United States