A Pilot Study of Activated T Cell Therapy for Refractory/Relapsed Neuroblastoma

Neuroblastoma Clinical Trial

Official title:

A Pilot Study of Activated T Cell Therapy for Refractory/Relapsed Neuroblastoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01802138
• Other study ID #: ILC_IIT_03
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Est. completion date: October 31, 2018

Study information

• Verified date: April 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Activated T cell were manufactured through in vitro T cell expansion of autologous T cell. We designed this study to determine the feasibility and safety of Activated T-lymphocyte cell therapy for refractory/relapsed neuroblastoma patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: October 31, 2018
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuroblastoma

Intervention

Biological:
• Activated T lymphocyte
intravenous dripping of 200 ml (10^9~2*10^10 lymphocytes) for 1 hour.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul	Chongno-gu

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	T cell count after in vitro expansion	T cell count after in vitro expansion; Evaluation of safety	up to 13 weeks
Secondary	Number of participants who showed response with Response Evaluation Criteria in Solid Tumors criteria	To determine the response rate; To evaluate 1 yr progression free survival and overall survival	up to 1 year