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

This study has been completed.
Sponsor:
Collaborators:
Tufts Medical Center
Ligand Pharmaceuticals
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00211198
First received: September 13, 2005
Last updated: February 29, 2008
Last verified: February 2008

September 13, 2005
February 29, 2008
May 2001
January 2005   (final data collection date for primary outcome measure)
To estimate response rates (CR + CCR + PR) according to CD25 status (CD25 positive and negative) after 4 cycles of ONTAK.
Same as current
Complete list of historical versions of study NCT00211198 on ClinicalTrials.gov Archive Site
  • 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
  • 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
Not Provided
Not Provided
 
Study of ONTAK® to Treat Cutaneous T-Cell Lymphoma (CTCL)
Open Label Study of ONTAK® (Denileukin Diftitox, DAB389IL-2) to Estimate Response in Cutaneous T-Cell Lymphoma (CTCL) According to CD25 Status

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma, T-Cell, Cutaneous
Drug: ONTAK (denileukin difitox, DAB389IL-2)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
January 2006
January 2005   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00211198
#33
Yes
Not Provided
Eisai Inc.
  • Tufts Medical Center
  • National Cancer Institute (NCI)
  • Ligand Pharmaceuticals
Study Chair: Francine Foss, M.D. Yale University
Eisai Inc.
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP