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Sponsored by: |
FDA Office of Orphan Products Development |
Information provided by: | FDA Office of Orphan Products Development |
ClinicalTrials.gov Identifier: | NCT00254332 |
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 |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Effect of Denileukin Diftitox in T-Regulatory Cells in CTCL Patients |
Estimated Enrollment: | 10 |
Study Start Date: | November 2005 |
Estimated Study Completion Date: | December 2008 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
Principal Investigator: | Larisa J. Geskin, M.D. | University of Pittsburgh |
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 |
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