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
Verified date | September 2018 |
Source | Samsung Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Samsung Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Samsung Medical Center |
Korea, Republic of,
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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