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

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ClinicalTrials.gov Identifier: NCT01807468
Recruitment Status : Active, not recruiting
First Posted : March 8, 2013
Last Update Posted : October 18, 2016
Sponsor:
Information provided by (Responsible Party):
KiWoong Sung, 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.


Condition or disease Intervention/treatment Phase
Neuroblastoma Ewing Sarcoma Rhabdomyosarcoma Osteosarcoma Soft Tissue Sarcoma Procedure: haploidentical stem cell transplantation and NK cell therapy Phase 2

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  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2013
Actual Primary Completion Date : December 2015
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Experimental: HaploSC+NK Procedure: haploidentical stem cell transplantation and NK cell therapy



Primary Outcome Measures :
  1. 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 Measures :
  1. 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


Other Outcome Measures:
  1. number of patients developing GVHD [ Time Frame: up to 1 year ]


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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01807468


Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Ki Woong Sung, MD, PhD Department of Pediatrics, Samsung Medical Center

Responsible Party: KiWoong Sung, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01807468     History of Changes
Other Study ID Numbers: CR0113061
First Posted: March 8, 2013    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: October 2016

Keywords provided by KiWoong Sung, Samsung Medical Center:
haploidentical stem cell transplantation
natural killer cell therapy
pediatric solid tumor

Additional relevant MeSH terms:
Sarcoma
Neuroblastoma
Osteosarcoma
Rhabdomyosarcoma
Sarcoma, Ewing
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Myosarcoma
Neoplasms, Muscle Tissue