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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00254332
• Other study ID #: IRB 0509084
• Status: Completed
• Phase: N/A
• First received: November 15, 2005
• Last updated: March 24, 2015
• Start date: November 2005
• Est. completion date: September 2007

Study information

• Verified date: December 2007
• Source: FDA Office of Orphan Products Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 and older

• diagnosed with CTCL

• able and willing to provide informed consent

• will be receiving denileukin diftitox per standard guidelines

Exclusion Criteria:

• prior history of receiving Ontak

• pregnancy

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	University of Pittsubrgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States,