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


Phase 2
N/A
21 Years
Not Enrolling
Both
Neuroblastoma, Ewing Sarcoma, Rhabdomyosarcoma, Osteosarcoma, Soft Tissue Sarcoma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of study patients with adverse events as a measure of safety of haploidentical stem cell transplantation and NK cell infusion

Outcome Time Frame:

within 30 days after transplantation

Safety Issue:

Yes

Principal Investigator

Ki Woong Sung, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Pediatrics, Samsung Medical Center

Authority:

Korea: Food and Drug Administration

Study ID:

CR0113061

NCT ID:

NCT01807468

Start Date:

May 2013

Completion Date:

December 2018

Related Keywords:

  • Neuroblastoma
  • Ewing Sarcoma
  • Rhabdomyosarcoma
  • Osteosarcoma
  • Soft Tissue Sarcoma
  • haploidentical stem cell transplantation
  • natural killer cell therapy
  • pediatric solid tumor
  • Neuroblastoma
  • Osteosarcoma
  • Rhabdomyosarcoma
  • Sarcoma, Ewing's
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Sarcoma

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