Finding studies
Finding studies
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Lead
Sumithira Vasu
PRIMARY OBJECTIVES: I. To determine the feasibility and safety of decitabine followed by natural killer (NK) cells and IL-2 (Interleukin). II. To define the specific toxicities and the dose limiting toxicity (DLT) of decitabine plus NK cells and IL-2. III. To determine the feasibility and safety of manufacturing processes for NK cells. SECONDARY OBJECTIVES: I. To determine the overall response rate (ORR). II. To determine the rate of complete remission (CR) to this regimen of decitabine plus NK cells and IL-2 (interleukin) in acute myeloid leukemia (AML). TERTIARY OBJECTIVES: I. To correlate the biological activity of decitabine as in upregulating ligands that mediate susceptibility to NK mediated cytotoxicity. II. To characterize the biological activity of infused NK cells and persistence as defined by NK chimerism. III. To evaluate if decitabine has immunosuppressive properties or modulates changes in endogenous cytokines in patients. OUTLINE: Patients receive decitabine intravenously (IV) over 60 minutes on days -4 to 0 and undergo infusion of allogeneic NK cells on day 0. Beginning 1 hour after infusion allogeneic NK cells, patients also receive aldesleukin subcutaneously (SC) every other day for 6 doses. After completion of study treatment, patients are followed up for 30 days.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
