Effect of Denileukin Diftitox on Immune System in CTCL Patients
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|ClinicalTrials.gov Identifier: NCT00254332|
Recruitment Status : Completed
First Posted : November 16, 2005
Last Update Posted : March 25, 2015
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|
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|
|Official Title:||Effect of Denileukin Diftitox in T-Regulatory Cells in CTCL Patients|
|Study Start Date :||November 2005|
|Estimated Study Completion Date :||September 2007|
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 ClinicalTrials.gov identifier (NCT number): NCT00254332
|United States, Pennsylvania|
|University of Pittsubrgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Larisa J. Geskin, M.D.||University of Pittsburgh|