RATIONALE: Giving an infusion of natural killer cells from a donor after a donor stem cell transplant may help kill any remaining cancer cells after the transplant. PURPOSE: This phase I/II trial is studying the side effects and best dose of donor natural killer cells when given after a donor stem cell transplant in treating patients with advanced cancer.
OBJECTIVES: Primary * To assess the safety of donor natural killer (NK) cell infusion after HLA-mismatched/haploidentical allogeneic hematopoietic stem cell transplantation from a familial donor in patients with advanced malignant disorders. * To determine the maximum number of donor NK cells that can be safely given to these patients. Secondary * To assess the clinical efficacy donor NK cell infusion, in terms of tumor response, response duration, and survival, in patients with progressive or recurrent malignant disorders. OUTLINE: This is a phase I, dose-escalation study followed by a phase II study. * Phase I: Patients receive an infusion of donor natural killer (NK) cells on days 18 and 21. * Phase II: Patients receive an infusion of donor NK cells on days 14 and 21. After completion of study treatment, patients are followed periodically.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
give patients donor-derived NK cells 2 to 3 weeks after HLA-haploidentical hematopoietic cell transplantation
University of Ulsan, Asan Medical Center
Seoul, South Korea
Safety
Safety will be evaluation in terms of transplantation outcomes as well as side effects of donor NK cell infusion
Time frame: 15 days to 1 year after transplantation
Clinical efficacy of donor NK cell infusion, in terms of tumor response, response duration, and survival
achievement of CR of underlying disease, CR duration
Time frame: 15 days to 1 year
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