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

September 17, 2018 updated by: KiWoong Sung, Samsung Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HaploSC+NK
Procedure: haploidentical stem cell transplantation and NK cell therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
within 30 days after transplantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
event-free survival and overall survival
Time Frame: 3 years after transplantation
efficacy of haploidentical stem cell transplantation and NK cell infusion in patients with high-risk solid tumors
3 years after transplantation

Other Outcome Measures

Outcome Measure
Time Frame
number of patients developing GVHD
Time Frame: up to 1 year
up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Ki Woong Sung, MD, PhD, Department of Pediatrics, Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Anticipated)

June 1, 2019

Study Registration Dates

First Submitted

February 26, 2013

First Submitted That Met QC Criteria

March 7, 2013

First Posted (Estimate)

March 8, 2013

Study Record Updates

Last Update Posted (Actual)

September 18, 2018

Last Update Submitted That Met QC Criteria

September 17, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR0113061

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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