Immune cell therapy for pediatric patients with brain tumor.
- Conditions
- Malignant brain tumor
- Registration Number
- JPRN-jRCTc030200051
- Lead Sponsor
- Kondo Akihide
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 3
(1)Diagnosed with malignant brain tumor.
(2)Patients scheduled to receive surgical resection, radiotherapy and chemotherapy as standard treatment.
(3)70 or over of Karnofsky Performance Status (KPS) or Lansky Performance Status (LPS) score.
(4)Life expectancy more than 2 months after initiation of the study therapy.
(5)Age ranging over 3 years old and under 15 years old.
(6)Possible to visit outpatient department.
(7)Adequate function of liver, kidney, and bone marrow when eligibility is confirmed.
(8)Written informed consent of guardian to participate this study.
(1)Apparent from the clinical manifestation of pulmonary fibrosis or interstitial pneumonia.
(2)A history of a serious drug allergy.
(3)Positive result of HIV or HTLV-1 antibody test.
(4)A serious cardiac disorder.
(5)Active autoimmune disorder.
(6)Cancers other than malignant brain tumor.
(7)An infectious disorder that is difficult to control.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety
- Secondary Outcome Measures
Name Time Method Efficacy, Immunological response, Quality of therapeutic cells, Quality of life