Effect of Denileukin Diftitox on Immune System in CTCL Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by FDA Office of Orphan Products Development.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00254332
First received: November 15, 2005
Last updated: December 26, 2007
Last verified: December 2007
  Purpose

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.


Condition
Cutaneous T-Cell Lymphoma
Sezary Syndrome
Mycosis Fungoides

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Effect of Denileukin Diftitox in T-Regulatory Cells in CTCL Patients

Resource links provided by NLM:


Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment: 10
Study Start Date: November 2005
Estimated Study Completion Date: December 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00254332

Contacts
Contact: Sue A. McCann, MSN, RN 412-624-3782 ext 3782 mccannsa@upmc.edu
Contact: Larisa J. Geskin, M.D. 412-648-7122 geskinlj@upmc.edu

Locations
United States, Pennsylvania
University of Pittsubrgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Sue A. McCann, MSN, RN, DNC    412-624-3782    mccannsa@upmc.edu   
Principal Investigator: Larisa J. Geskin, M.D.         
Sub-Investigator: Rodolfof Chirinos, M.D.         
Sub-Investigator: Kristina Paley, M.D.         
Sub-Investigator: Sue A. McCann, MSN, RN, DNC         
Sponsors and Collaborators
Investigators
Principal Investigator: Larisa J. Geskin, M.D. University of Pittsburgh
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00254332     History of Changes
Other Study ID Numbers: IRB 0509084
Study First Received: November 15, 2005
Last Updated: December 26, 2007
Health Authority: United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:
Cutaneous T-cell Lymphoma
Sezary Syndrome
Mycosis Fungoides
Denileukin Diftitox

Additional relevant MeSH terms:
Lymphoma
Mycoses
Mycosis Fungoides
Sezary Syndrome
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Denileukin diftitox
Interleukin-2
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 28, 2014