Malignant glioma (Grade 3 or 4 glioma in the WHO criteria)
Conditions
Interventions
The FCs of glioma cells, glioma initiating cells, and dendritic cells will be inoculated intradermally at the cervical region. FC-inoculation will be repeated 3~10 times in each 28-day cycle. This the
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 malignant glioma by a MRI or CT image, and needs to receive a surgical tumor resection. 2) A patient who is tolerable to receive gathering peripheral blood mononuclear cells by an apheresis method. 3)A patient who satisfies following criteria without functional failure of major organs, such as heart, lung, liver, kidney, and bone marrow etc. WBC > 2,500/microL Platelet > 75,000/microL Hb > 9.0/dL Serum creatinine < 1.5mg/dL Total bilirubin < 2.0mg/dL AST, ALT < 100U/L 4)A patient who has grade 0 to 2 of the Performance Status. 5)A patient who is suspected to be alive for more than 3 months. 6)A patient who does not have multiple primary cancer. <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 malignant glioma (Grade 3 or 4 glioma in the WHO criteria). 2)A patient who has autologous cultured tumor cells available to fuse with dendritic cells.
Exclusion criteria
Exclusion criteria: 1)A patient who has an allergy to biological medicines. 2)A patient who has a past or current history of autoimmune disease. 3)A patient who has positive of HBs antigen, HIV antibody, HCV antibody, or HTLV antibody. 4)A patient who has sever immune deficiency. 5)A patient who is administrated steroids for a long period, and is difficult to stop it. 6)A patient who has sever infectious disease. 7)A patient who has sever lung disease (Class 3 or more in the Hugh-Jones classification). 8)A patient who has sever heart disease (Class 3 or more in the NYHA). 9)A patient who has uncontrollable diabetes. 10)A pregnant or lactating patient. 11)A patient who is involved in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year overall survival (OS) rate (a group of initially diagnosed grade 4 glioma) 3-year OS rate (a group of initially diagnosed grade 3 glioma) 1-year OS rate (a group of recurrent glioma) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-year progression free survival (PFS) rate (a group of initially diagnosed grade 4 glioma) 2-year PFS rate (a group of initially diagnosed grade 3 glioma) 6-month PFS rate (a group of recurrent glioma) | — |
Countries
Japan
Contacts
Public ContactYasuharu Akasaki
Jikei University School of Medicine Department of Neurosurgery
Outcome results
None listed