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ONTAK to Estimate Response in Cutaneous T-Cell Lymphoma According to CD25 Status
This study is ongoing, but not recruiting participants.
Sponsored by: Ohio State University Comprehensive Cancer Center
Information provided by: Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00279396
  Purpose

Purpose: This study will evaluate the efficacy of denileukin diftitox according to the CD25 status in patients with cutaneous T-cell lymphoma. Researchers are seeking information about differences between response rates in patients who are CD25 positive or CD25 negative. Quality of life will be measured in all patients.


Condition Intervention Phase
Non-Hodgkin's Lymphoma
Drug: denileukin diftitox
Phase III

MedlinePlus related topics: Lymphoma
Drug Information available for: Denileukin diftitox
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Open Label Study of ONTAK (Denileukin Diftitox, DAB389 IL-2) to Estimate Response in Cutaneous T-Cell Lymphoma (CTCL) According to CD25 Status

Further study details as provided by Ohio State University Comprehensive Cancer Center:

Estimated Enrollment: 90
Study Start Date: November 2004
Detailed Description:

Rationale: Some therapies for cancer target both healthy and diseased cells in the body. Newer treatments have a more targeted approach that focus on tumor cells, including the drug offered in this study called denileukin diftitox. This drug targets specific receptors on malignant cells while minimizing damage to normal cells not expressing the receptor. Denileukin Diftitox attaches to the cell surface of T-cell lymphocytes, which most commonly cause skin lymphomas. Previous studies have demonstrated denileukin diftitox’s ability to kill certain leukemia and lymphoma cells due to the drug’s ability to attach to the T-cell lymphocytes and a protein called CD25. Some T-cell lymphocytes have the protein CD25 on their cell surface, while others do not. CD25 helps to create an immune response. Denileukin Diftitox is already approved for persistent or recurrent T-cell lymphoma with malignant cells that express CD25. The current study will test denileukin diftitox in patients with cutaneous T-cell lymphoma to gain information about treatment efficacy for patients who are CD25 positive or CD25 negative.

Treatment: Patients in this study will receive denileukin diftitox. This drug will be administered through intravenous infusions. Denileukin diftitox will be given for five consecutive days. This schedule will be repeated every three weeks. Several tests and exams will be conducted throughout the study, including imaging exams before each five day treatment period with denileukin diftitox. Treatments will be discontinued due to disease growth or unacceptable side effects. Patients responding to denileukin diftitox will continue receiving the drug on the same schedule. Those with a complete response will receive one additional five day treatment. All patients will be closely monitored.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cutaneous T-cell lymphoma (CTCL)

Exclusion Criteria:

  • Pregnant or nursing
  • Previous denileukin diftitox (ONTAK®) usage
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00279396

Locations
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Principal Investigator: Pierluigi Porcu Ohio State University
  More Information

Study ID Numbers: OSU-0405
Study First Received: January 17, 2006
Last Updated: December 26, 2006
ClinicalTrials.gov Identifier: NCT00279396  
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University Comprehensive Cancer Center:
CD25
Cutaneous T-Cell Lymphoma

Study placed in the following topic categories:
Sezary syndrome
Immunoproliferative Disorders
Cutaneous T-cell lymphoma
Lymphoma, small cleaved-cell, diffuse
Sezary Syndrome
Mycosis Fungoides
Mycoses
Lymphatic Diseases
Interleukin-2
Denileukin diftitox
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Lymphoma, T-Cell, Cutaneous

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Sensory System Agents
Analgesics, Non-Narcotic
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009