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

Overview

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.

Full Title of Study: “Open Label Study of ONTAK® (Denileukin Diftitox, DAB389IL-2) to Estimate Response in Cutaneous T-Cell Lymphoma (CTCL) According to CD25 Status”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2005

Interventions

  • Drug: ONTAK (denileukin difitox, DAB389IL-2)

Clinical Trial Outcome Measures

Primary Measures

  • To estimate response rates (CR + CCR + PR) according to CD25 status (CD25 positive and negative) after 4 cycles of ONTAK.

Secondary Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Eisai Inc.
  • Collaborator
    • Tufts Medical Center
  • Overall Official(s)
    • Francine Foss, M.D., Study Chair, Yale University

References

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.

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