Trial Information
A Pilot Study of Activated T Cell Therapy for Refractory/Relapsed Neuroblastoma
Inclusion Criteria:
- Informed consent
- Age 21 years or younger
- Histologically confirmed neuroblastoma
- Progressive disease after standard treatment or relapsed patient
- ECOG scale (ECOG-PS) ≤2
- Expected survival at least 3 months
Exclusion Criteria:
- Patients with autoimmune disease
- Patients with immunodeficiency
- Other malignancy 5 year prior to this study
- Severe organ dysfunction
- Severe allergic disease
- Severe psychiatric disorder
- Pregnancy or lactating woman
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
T cell count after in vitro expansion
Outcome Description:
T cell count after in vitro expansion
Evaluation of safety
Outcome Time Frame:
up to 13 weeks
Safety Issue:
Yes
Authority:
Korea: Food and Drug Administration
Study ID:
ILC_IIT_03
NCT ID:
NCT01802138
Start Date:
February 2013
Completion Date:
December 2014
Related Keywords:
- Neuroblastoma
- refractory/relapsed neuroblastoma patients
- Neuroblastoma