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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2019-06-30

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.

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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.

Conditions

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Neuroblastoma Ewing Sarcoma Rhabdomyosarcoma Osteosarcoma Soft Tissue Sarcoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HaploSC+NK

Group Type EXPERIMENTAL

haploidentical stem cell transplantation and NK cell therapy

Intervention Type PROCEDURE

Interventions

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haploidentical stem cell transplantation and NK cell therapy

Intervention Type PROCEDURE

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