Pediatric brain tumor
Conditions
Interventions
1) Mature dendritic cells (DCs) are generated from PBMCs by an apheresis collection method, and cultured in AIM-1 medum with GM-CSF, IL-4, TNF-alfa.
2) Generation of primary cultured glioma cells from
Sponsors
Yanagisaw Takaaki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients will be tentatively enrolled in this clinical trial, when they satisfy the following tentative inclusion criteria. 1) A patient who is suspected a relapse or refractory pediatric brain tumor with poor prognosis. 2) A patient who needs to receive a surgical tumor resection. 3) A patient who is tolerable to receive gathering peripheral blood mononuclear cells by an apheresis method. 4) Age at enrollment is 3 to 16 years) have provided written voluntary consent to participation in this study after fully receiving and understanding the information about this study. 9) A patient who satisfies following criteria without functional failure of major organs, such as heart, lung, liver, kidney, and bone marrow etc. Tentatively enrolled patients will be truly enrolled as a subject of this clinical trial, when they satisfy the following final inclusion criteria. 1) A patient who is histologically proven recurrent or refractory brain tumor. 2) A patient who has autologous cultured tumor cells available to fuse with dendritic cells.
Exclusion criteria
Exclusion criteria: 1) A patient who has sever immune deficiency. 2) A patient who has a past or current history of autoimmune disease. 3) A patient who is administrated immunosuppressive agents for a long period, and is difficult to stop it. 4) A patient who received chemotherapy (including with molecular target therapy) or radiotherapy within 21 days. 5) A patients who underwent allogeneic hematopoietic stem cell transplant. 6) A patient who had recovered from some viral infection (influenza virus or gastroenteritis) within 14 days. 7) A patient who has an allergy to biological medicines. 8) A patient who previously received WT1 peptide vaccine or other immunotherapy (except our dendritic cell vaccine). 9) A patient who has positive of HBs antigen, HIV antibody, HCV antibody, or HTLV antibody. 10) A patient who has severe infectious disease over Grade 3 of CTCAE v4.0. 11) A patient who has sever lung disease (Class 3 or more in the Hugh-Jones classification). 12) A patient who has severe heart disease (Class 3 or more in the NYHA). 13) A patient who has some uncontrollable complication. 14) A pregnant or lactating patient. 15) A patient who is involved in other clinical trials. 16) A patients who are inappropriate for participation in the study for other reasons in the opinion of the investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety (ratio and severity of adverse events) | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-year overall survival (OS) rate, 1-year progression free survival (PFS) rate, iRANO criteria | — |
Countries
Japan
Contacts
Public ContactYasuharu Akasaki
The Jikei University Hospital
Outcome results
None listed