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Effect of Denileukin Diftitox on Immune System in CTCL Patients

This study is currently recruiting participants.
Verified by FDA Office of Orphan Products Development, December 2007

Sponsored by: FDA Office of Orphan Products Development
Information provided by: FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier: NCT00254332
  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

MedlinePlus related topics:   Fungal Infections    Lymphoma   

Drug Information available for:   Denileukin diftitox   

U.S. FDA Resources

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

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

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


Study ID Numbers:   IRB 0509084
First Received:   November 15, 2005
Last Updated:   December 26, 2007
ClinicalTrials.gov Identifier:   NCT00254332
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  

Study placed in the following topic categories:
Sezary syndrome
Immunoproliferative Disorders
Cutaneous T-cell lymphoma
Sezary Syndrome
Mycosis Fungoides
Mycoses
Lymphatic Diseases
Interleukin-2
Lymphoma, T-Cell
Denileukin diftitox
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma
Lymphoma, T-Cell, Cutaneous

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Disease
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Neoplasms
Pathologic Processes
Analgesics, Non-Narcotic
Sensory System Agents
Syndrome
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 06, 2008




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