Overview

This trial is active, not recruiting.

Conditions neuroblastoma, ewing sarcoma, rhabdomyosarcoma, osteosarcoma, soft tissue sarcoma
Treatment haploidentical stem cell transplantation and nk cell therapy
Phase phase 2
Sponsor Samsung Medical Center
Start date May 2013
End date December 2015
Trial size 12 participants
Trial identifier NCT01807468, CR0113061

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
haploidentical stem cell transplantation and nk cell therapy

Primary Outcomes

Measure
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 Outcomes

Measure
event-free survival and overall survival
time frame: 3 years after transplantation

Eligibility Criteria

Male or female participants up to 21 years old.

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

Additional Information

Official title Haploidentical Stem Cell Transplantation Followed by NK Cell Infusion in Patients With High-risk Solid Tumors Who Failed Autologous Stem Cell Transplantation
Principal investigator Ki Woong Sung, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Samsung Medical Center.