Effect of Denileukin Diftitox on Immune System in CTCL Patients

Mycosis Fungoides Clinical Trial

Official title: Effect of Denileukin Diftitox in T-Regulatory Cells in CTCL Patients

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

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

• NCT number: NCT00254332
• Study type: Observational
• Source: FDA Office of Orphan Products Development
• Status: Completed
• Phase: N/A
• Start date: November 2005
• Completion date: September 2007