Effect of Denileukin Diftitox on Immune System in CTCL Patients
Recruitment status was Recruiting
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.
Cutaneous T-Cell Lymphoma
|Study Design:||Time Perspective: Prospective|
|Official Title:||Effect of Denileukin Diftitox in T-Regulatory Cells in CTCL Patients|
|Study Start Date:||November 2005|
|Estimated Study Completion Date:||December 2008|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00254332
|Contact: Sue A. McCann, MSN, RN||412-624-3782 ext firstname.lastname@example.org|
|Contact: Larisa J. Geskin, M.D.||email@example.com|
|United States, Pennsylvania|
|University of Pittsubrgh Medical Center||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15213|
|Contact: Sue A. McCann, MSN, RN, DNC 412-624-3782 firstname.lastname@example.org|
|Principal Investigator: Larisa J. Geskin, M.D.|
|Sub-Investigator: Rodolfof Chirinos, M.D.|
|Sub-Investigator: Kristina Paley, M.D.|
|Sub-Investigator: Sue A. McCann, MSN, RN, DNC|
|Principal Investigator:||Larisa J. Geskin, M.D.||University of Pittsburgh|