NCT00254332

Effect of Denileukin Diftitox on Immune System in CTCL Patients

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 10 (estimated)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

• Cutaneous T-cell Lymphoma
• Sezary Syndrome
• Mycosis Fungoides

Timeline

• Start date: 2005-11-01
• Completion: 2007-09-01
• First posted: 2005-11-16
• Last updated: 2015-03-25

Locations

1 site across 1 country: United States