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

This study is currently recruiting participants.
Verified November 2013 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01802138
First received: February 21, 2013
Last updated: November 17, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Neuroblastoma
Biological: Activated T lymphocyte

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Activated T Cell Therapy for Refractory/Relapsed Neuroblastoma

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • T cell count after in vitro expansion [ Time Frame: up to 13 weeks ] [ Designated as safety issue: Yes ]

    T cell count after in vitro expansion

    Evaluation of safety



Secondary Outcome Measures:
  • Number of participants who showed response with Response Evaluation Criteria in Solid Tumors criteria [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]

    To determine the response rate

    To evaluate 1 yr progression free survival and overall survival



Estimated Enrollment: 6
Study Start Date: February 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Activated T-lymphocyte

This was designed as a single-center, single group clinical trial, and subjects include patients with refractory refractory/relapsed neuroblastoma.

If subjects agree to participate in the clinical trial by signing a written consent, only appropriate subjects, who meet the criteria on the examinations and tests, will undergo this clinical trial. To participate in the clinical trial, subject's blood of more than 60 ml should be withdrawn to make a study drug at least 3 weeks before administration. Subjects should visit to hospital according to the protocol and receive a study drug. Therapeutic response rate, overall survival rate, time to progression should be investigated.

Biological: Activated T lymphocyte
intravenous dripping of 200 ml (10^9~2*10^10 lymphocytes) for 1 hour.
Other Name: Immuncell-LC

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01802138

Contacts
Contact: Hyoung Jin Kang, MD, Ph.D 82 2 2072 3304 kanghj@snu.ac.kr
Contact: Ji Won Lee, MD 82 2 2072 4192 agnesjw@hanmail.net

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Chongno-gu, Korea, Republic of
Contact: Hyoung Jin Kang, MD, Ph.D    82 2 2072 3304    kanghj@snu.ac.kr   
Principal Investigator: Hee Young Shin, MD, Ph.D         
Sponsors and Collaborators
Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01802138     History of Changes
Other Study ID Numbers: ILC_IIT_03
Study First Received: February 21, 2013
Last Updated: November 17, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
refractory/relapsed neuroblastoma patients

Additional relevant MeSH terms:
Neuroblastoma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on April 22, 2014