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To evaluate feasibility and efficacy of haploidentical stem cell transplantation in patients with high-risk solid tumors who failed after tandem high-dose chemotherapy and autologous stem cell transplantation.
To evaluate feasibility and efficacy of NK cell infusion after haploidentical stem cell transplantation in patients with high-risk solid tumors who failed after tandem high-dose chemotherapy and autologous stem cell transplantation.
HaploSCT following reduced-intensity conditioning (RIC) regimen will be performed in patients with high-risk solid tumors. Both parents will be evaluated for their KIR genotype and phenotype and the one with the greatest degree of KIR-L mismatch with the patient will be selected as the donor. In addition, ex-vivo expanded NK cells derived from the donor will then be administered after haploSCT to increase the GVT effect. Low-dose IL-2 will be given after expanded NK cell infusion to enhance NK cell alloreactivity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HaploSC+NK | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| haploidentical stem cell transplantation and NK cell therapy | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of study patients with adverse events as a measure of safety of haploidentical stem cell transplantation and NK cell infusion | within 30 days after transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| event-free survival and overall survival | efficacy of haploidentical stem cell transplantation and NK cell infusion in patients with high-risk solid tumors | 3 years after transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| number of patients developing GVHD | up to 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ki Woong Sung, MD, PhD | Department of Pediatrics, Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | 135-710 | South Korea |
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| ID | Term |
|---|---|
| D009447 | Neuroblastoma |
| D012512 | Sarcoma, Ewing |
| D012208 | Rhabdomyosarcoma |
| D012516 | Osteosarcoma |
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009217 | Myosarcoma |
| D009379 | Neoplasms, Muscle Tissue |
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