Effect of Denileukin Diftitox on Immune System in CTCL Patients
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, Lymphoma |
| Therapuetic Areas: | Immunology / Infectious Diseases, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/16/2015 |
| Start Date: | November 2005 |
| End Date: | December 2008 |
| Contact: | Sue A. McCann, MSN, RN |
| Email: | mccannsa@upmc.edu |
| Phone: | 412-624-3782 |
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.
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.
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.
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.
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
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