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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00211198
Other study ID # #33
Secondary ID
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 ONTAKĀ® 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


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
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Completed NCT00050999 - Study of ONTAK (Denileukin Diftitox) in Cutaneous T-Cell Lymphoma (CTCL) Patients Phase 4
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Terminated NCT02811783 - Naloxone Hydrochloride Study for Relief of Pruritus in Patients With MF or SS Forms of CTCL Phase 3