Effect of Denileukin Diftitox on Immune System in CTCL Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00254332
Recruitment Status : Completed
First Posted : November 16, 2005
Last Update Posted : March 25, 2015
Information provided by:
FDA Office of Orphan Products Development

Brief Summary:

This is a blood and tissue study to determine the effect of the drug called denileukin diftitox on the immune system cells that may be involved in patient response to their cutaneous t-cell lymphoma.

Patients who are undergoing standard of care therapy with denileukin diftitox will be invited to participate. Blood and tissue samples will be obtained at baseline, day 5 and day 19 in up to the first 4 cycles of denileukin diftitox.

Condition or disease
Cutaneous T-cell Lymphoma Sezary Syndrome Mycosis Fungoides

Detailed Description:

Although the etiology of CTCL is not fully understood, it is believed to be a malignancy proliferation of a "memory" T-cell in the context of Th2-type cytokine profile and suppressed cytotoxic T-cell (CTL) immunity. T-regulatory (T-regs) cells may be important in CTCL in the setting of immunotherapy. Removal of T-regs would result in enhanced immune responses in vitro, which may translate into augmentation of the anti-tumor immune response and durable clinical responses in vivo. We propose to evaluate effects of ONTAK on the T-reg cell subset in patients undergoing routine therapy with ONTAK. We will evaluate T-reg subsets in peripheral blood and tumor tissues from the patients both phenotypically using multi-color FACS analysis and confocal microscopy, and functionally in MLRs and ELISpot assays with baseline, day 5 and 19 blood samples in up to four cycles.

Completion date provided represents the completion date of the grant per OOPD records

Study Type : Observational
Estimated Enrollment : 10 participants
Time Perspective: Prospective
Official Title: Effect of Denileukin Diftitox in T-Regulatory Cells in CTCL Patients
Study Start Date : November 2005
Study Completion Date : September 2007

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18 and older
  • diagnosed with CTCL
  • able and willing to provide informed consent
  • will be receiving denileukin diftitox per standard guidelines

Exclusion Criteria:

  • prior history of receiving Ontak
  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00254332

United States, Pennsylvania
University of Pittsubrgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Principal Investigator: Larisa J. Geskin, M.D. University of Pittsburgh Identifier: NCT00254332     History of Changes
Other Study ID Numbers: IRB 0509084
First Posted: November 16, 2005    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: December 2007

Keywords provided by FDA Office of Orphan Products Development:
Cutaneous T-cell Lymphoma
Sezary Syndrome
Mycosis Fungoides
Denileukin Diftitox

Additional relevant MeSH terms:
Lymphoma, T-Cell
Mycosis Fungoides
Sezary Syndrome
Lymphoma, T-Cell, Cutaneous
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Denileukin diftitox
Antineoplastic Agents
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs