Haploidentical Stem Cell Transplantation and NK Cell Therapy in Patients With High-risk Solid Tumors
This trial is active, not recruiting.
|Conditions||neuroblastoma, ewing sarcoma, rhabdomyosarcoma, osteosarcoma, soft tissue sarcoma|
|Treatment||haploidentical stem cell transplantation and nk cell therapy|
|Sponsor||Samsung Medical Center|
|Start date||May 2013|
|End date||December 2015|
|Trial size||12 participants|
|Trial identifier||NCT01807468, CR0113061|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Number of study patients with adverse events as a measure of safety of haploidentical stem cell transplantation and NK cell infusion
time frame: within 30 days after transplantation
event-free survival and overall survival
time frame: 3 years after transplantation
Male or female participants up to 21 years old.
Inclusion Criteria: - age < 21 years old - Patients with high-risk solid tumors who failed prior HDCT/autoSCT - Patients with a suitable haploidentical donor - High-risk solid tumors include high-risk neuroblastoma, metastatic or relapsed Ewing sarcoma, relapsed osteosarcoma, high-risk brain tumors, relapsed germ cell tumors, relapsed soft tissue sarcoma, relapsed rhabdomyosarcoma, and etc. - stable disease with salvage chemotherapy after relapse Exclusion Criteria: - organ dysfunction(NCI common toxicity criteria grade > 2) - progression of disease despite salvage chemotherapy
|Official title||Haploidentical Stem Cell Transplantation Followed by NK Cell Infusion in Patients With High-risk Solid Tumors Who Failed Autologous Stem Cell Transplantation|
|Principal investigator||Ki Woong Sung, MD, PhD|
|Description||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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