Pediatric refractory brain tumor
Conditions
Interventions
In Phase 1, we evaluate the safety (DLT) by three steps according to 3+3 design method. In Phase 2, we evaluate the safety and efficacy with 0.5-10 x10^6 cells in dendritic cell count. Fusion cell in
Sponsors
Jikei University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: <Tentative 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 <25 year-old 5) A patient who has grade 0 to 3 of the Performance Status. Patients with a PS score of 4 due to neurological symptoms associated with the primary disease may be eligible if patients could go to outpatient clinic without any respiratory supports. 6) A patient who is suspected to be alive for more than 3 months. 7) A patient who does not have multiple primary cancer. 8) A patient for whom either the legally acceptable representative or the patient (if aged > 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. WBC > 1,500/microL Platelet > 50,000/microL Hb > 9.0/dL Serum creatinine < 3-fold the upper limit of the normal range based on each age (ULN) Total bilirubin < 3-fold the ULN AST, ALT < 120U/L <Final inclusion criteria> 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. 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-year overall survival (OS) rate, 1-year progression free survival (PFS) rate, iRANO criteria | — |
Countries
Japan
Contacts
Public ContactMasayoshi Yamaoka
Jikei University School of Medicine Pediatrics
Outcome results
None listed