Finding studies
Finding studies
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Lead
Masonic Cancer Center, University of Minnesota
OBJECTIVES: Primary * To evaluate the in vivo expansion of an infused allogeneic natural killer (NK) cell product following a preparative regimen comprising cyclophosphamide, fludarabine phosphate, and total-body irradiation in treating patients with recurrent and/or metastatic ovarian, fallopian tube, or primary peritoneal cancer. Secondary * To characterize the quantitative and qualitative toxicities of this treatment regimen. * To estimate disease response (complete or partial response) or clinical benefit (stable disease for \> 6 months) as measured by Response Evaluation Criteria in Solid Tumours (RECIST) criteria. * To estimate time to progression and overall survival. * To estimate the association between clinical response and donor/recipient KIR ligand matching status. Tertiary * To evaluate immune activation of the in vivo expanded haploidentical allogeneic NK cells and its effect on the immune system. OUTLINE: * Preparative regimen: Patients receive fludarabine phosphate IV on days 6 to 2 preceding natural killer (NK) cell infusion and cyclophosphamide IV on days 5 and 4 preceding NK cell infusion. Patients also undergo total-body irradiation on day 1 preceding NK cell infusion. * Allogeneic natural killer (NK) cell administration and aldesleukin: Patients receive aldesleukin-activated haploidentical allogeneic NK cells intravenously (IV) on day 0. Beginning 4-6 hours after allogeneic NK cell infusion, patients receive aldesleukin subcutaneously (SC) 3 times a week for 6 doses. Patients achieving any initial response (complete or partial response) or a clinical benefit (stable disease for \> 6 months) who progress after 6 months may receive 1 re-treatment course as above. Blood samples are collected at baseline, on days 0, 7, 14, and 28, and then at 2 and 3 months post NK cell infusion for cytokine measurements, immunophenotyping, functional analyses, and testing for persistence of donor cells. After completion of study treatment, patients are followed periodically for at least 1 year.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
