Effect of Denileukin Diftitox on Immune System in CTCL Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Mycosis Fungoides; Sezary Syndrome; Cutaneous T-cell Lymphoma

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

• Study Type: Observational
• Enrollment (Anticipated): 10

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsubrgh Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: Larisa J. Geskin, M.D., University of Pittsburgh

Study record dates

Study Major Dates

• Study Start: November 1, 2005
• Study Completion: September 1, 2007

Study Registration Dates

• First Submitted: November 15, 2005
• First Submitted That Met QC Criteria: November 15, 2005
• First Posted (Estimate): November 16, 2005

Study Record Updates

• Last Update Posted (Estimate): March 25, 2015
• Last Update Submitted That Met QC Criteria: March 24, 2015
• Last Verified: December 1, 2007

More Information

Terms related to this study

• Keywords: Mycosis Fungoides; Denileukin Diftitox; Cutaneous T-cell Lymphoma; Sezary Syndrome
• Additional Relevant MeSH Terms: Infections; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Bacterial Infections and Mycoses; Lymphoma; Mycoses; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, T-Cell, Cutaneous; Mycosis Fungoides; Sezary Syndrome
• Other Study ID Numbers: IRB 0509084