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NCT01807468 Clinical Trial

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

Neuroblastoma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01807468
Other study ID # CR0113061
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date May 2013
Est. completion date June 2019

Study information
Verified date September 2018
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 12
Est. completion date June 2019
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender All
Age group N/A to 21 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• haploidentical stem cell transplantation and NK cell therapy

Locations
Country Name City State
Korea, Republic of Samsung Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Other number of patients developing GVHD up to 1 year
Primary Number of study patients with adverse events as a measure of safety of haploidentical stem cell transplantation and NK cell infusion within 30 days after transplantation
Secondary event-free survival and overall survival efficacy of haploidentical stem cell transplantation and NK cell infusion in patients with high-risk solid tumors 3 years after transplantation
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