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Sponsors and Collaborators: |
Eisai Medical Research Inc. Tufts Medical Center National Cancer Institute (NCI) Ligand Pharmaceuticals |
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Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00211198 |
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.
Condition | Intervention | Phase |
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Lymphoma, T-Cell, Cutaneous |
Drug: ONTAK (denileukin difitox, DAB389IL-2) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Open Label Study of ONTAK® (Denileukin Diftitox, DAB389IL-2) to Estimate Response in Cutaneous T-Cell Lymphoma (CTCL) According to CD25 Status |
Estimated Enrollment: | 60 |
Study Start Date: | May 2001 |
Study Completion Date: | January 2006 |
Primary Completion Date: | January 2005 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
City of Hope National Medical Center | |
Duarte, California, United States, 91010 | |
United States, Connecticut | |
Yale University School of Medicine | |
New Haven, Connecticut, United States, 06520 | |
United States, Iowa | |
The University of Iowa | |
Iowa City, Iowa, United States, 52242 | |
United States, Massachusetts | |
New England Medical Center | |
Boston, Massachusetts, United States | |
United States, Ohio | |
University Hospitals of Cleveland | |
Cleveland, Ohio, United States, 44106 | |
Ohio State University | |
Columbus, Ohio, United States, 43210 | |
United States, Pennsylvania | |
University of Pittsburgh | |
Pittsburgh, Pennsylvania, United States, 15213 | |
United States, Tennessee | |
Vanderbilt University | |
Nashville, Tennessee, United States, 37232 | |
United States, Texas | |
The University of Texas MD Anderson Cancer Center | |
Houston, Texas, United States, 77030-4009 |
Study Chair: | Francine Foss, M.D. | Yale University |
Study ID Numbers: | #33 |
Study First Received: | September 13, 2005 |
Last Updated: | February 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00211198 |
Health Authority: | United States: Food and Drug Administration |
Cutaneous T-cell lymphoma ONTAK CD25 |
Sezary syndrome Immunoproliferative Disorders Cutaneous T-cell lymphoma Sezary Syndrome Mycosis Fungoides Mycoses Lymphatic Diseases |
Lymphoma, T-Cell Denileukin diftitox Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma Lymphoma, T-Cell, Cutaneous |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |