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

Phase 2

• Conditions: Neuroblastoma; Soft Tissue Sarcoma; Ewing Sarcoma; Rhabdomyosarcoma; Osteosarcoma
• Interventions: Procedure: haploidentical stem cell transplantation and NK cell therapy

• Registration Number: NCT01807468
• Lead Sponsor: Samsung Medical Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-02-26
• Study First Submitted QC: 2013-03-07
• Study First Posted: 2013-03-08
• Study Start: 2013-05
• Primary Completion: 2015-12
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-17
• Last Update Posted: 2018-09-18
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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

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Exclusion Criteria

• organ dysfunction(NCI common toxicity criteria grade > 2)
• progression of disease despite salvage chemotherapy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HaploSC+NK	haploidentical stem cell transplantation and NK cell therapy	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of