Haploidentical Stem Cell Transplantation and NK Cell Therapy in Patients With High-risk Solid Tumors

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Haploidentical Stem Cell Transplantation Followed by NK Cell Infusion in Patients With High-risk Solid Tumors Who Failed Autologous Stem Cell Transplantation

Conditions
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Neuroblastoma, Ewing Sarcoma, Rhabdomyosarcoma, Osteosarcoma, Soft Tissue Sarcoma

Intervention / Treatment
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* Procedure: haploidentical stem cell transplantation and NK cell therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HaploSC+NK<br> | Procedure: haploidentical stem cell transplantation and NK cell therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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haploidentical stem cell transplantation, natural killer cell therapy, pediatric solid tumor