Trial Information

Effect of Denileukin Diftitox in T-Regulatory Cells in CTCL Patients

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.