This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This study will test the hypothesis that reducing the number of circulating CD4+CD25+ regulatory T-cells will enhance tumor immunity in patients with cancer. It is also designed to establish a safe and efficacious Ontak dosing schedule effecting this reduction, and to identify toxicities, if any, which may be related to treatment with Ontak. Three patients will be enrolled initially at an Ontak dose of 9ug/kg. The cohorts of the 3 patients will be studies until a dose of Ontak safely reducing the number of circulating CD4+CD25+ regulatory T-cells by 0.5l log is achieved. No more than 5 cohorts (15 patients) will be studied. At the dose that results in the desired goal, a tumor-specific patient population will be recruited to satisfy Phase II criteria. The present study will be amended appropriately or a new study will be written to accommodate the expanded population at the dose which produces the desired biological effect. Anticipated accrual of all study participants will take one year. Follow-up includes history and physical examination and blood draws for immunologic studies/assays approximately 30 days after completion of treatment. If patients experience adverse reactions to their Ontak infusion, an additional visit will take place within 7 days of the reaction in order to draw another blood sample to measure liver/kidney function and Treg counts. Additional paracentesis will also be requested, but is not mandatory.
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