Ewing Sarcoma, Neuroblastoma, Osteosarcoma, Rhabdomyosarcoma, Soft Tissue Sarcoma
Conditions
Keywords
haploidentical stem cell transplantation, natural killer cell therapy, pediatric solid tumor
Brief summary
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.
Detailed 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.
Interventions
PROCEDUREhaploidentical stem cell transplantation and NK cell therapy
Sponsors
Samsung Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| event-free survival and overall survival | 3 years after transplantation | efficacy of haploidentical stem cell transplantation and NK cell infusion in patients with high-risk solid tumors |
Other
| Measure | Time frame |
|---|---|
| number of patients developing GVHD | up to 1 year |
Countries
South Korea
Outcome results
None listed