Back to resultsHaploidentical Stem Cell Transplantation and NK Cell Therapy in Patients With High-risk Solid Tumors
Primary Purpose
Neuroblastoma, Ewing Sarcoma, Rhabdomyosarcoma
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
haploidentical stem cell transplantation and NK cell therapy
Sponsored by
About this trial
This is an interventional treatment trial for Neuroblastoma focused on measuring haploidentical stem cell transplantation, natural killer cell therapy, pediatric solid tumor
Eligibility Criteria
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
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HaploSC+NK
Arm Description
Outcomes
Primary Outcome Measures
Number of study patients with adverse events as a measure of safety of haploidentical stem cell transplantation and NK cell infusion
Secondary Outcome Measures
event-free survival and overall survival
efficacy of haploidentical stem cell transplantation and NK cell infusion in patients with high-risk solid tumors
Full Information
NCT ID
NCT01807468
First Posted
February 26, 2013
Last Updated
September 17, 2018
Sponsor
Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01807468
Brief Title
Haploidentical Stem Cell Transplantation and NK Cell Therapy in Patients With High-risk Solid Tumors
Official Title
Haploidentical Stem Cell Transplantation Followed by NK Cell Infusion in Patients With High-risk Solid Tumors Who Failed Autologous Stem Cell Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
June 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroblastoma, Ewing Sarcoma, Rhabdomyosarcoma, Osteosarcoma, Soft Tissue Sarcoma
Keywords
haploidentical stem cell transplantation, natural killer cell therapy, pediatric solid tumor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HaploSC+NK
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
haploidentical stem cell transplantation and NK cell therapy
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
event-free survival and overall survival
Description
efficacy of haploidentical stem cell transplantation and NK cell infusion in patients with high-risk solid tumors
Time Frame
3 years after transplantation
Other Pre-specified Outcome Measures:
Title
number of patients developing GVHD
Time Frame
up to 1 year
10. Eligibility
Sex
All
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ki Woong Sung, MD, PhD
Organizational Affiliation
Department of Pediatrics, Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Haploidentical Stem Cell Transplantation and NK Cell Therapy in Patients With High-risk Solid Tumors
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