glioma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Diagnosed with IDH-unmutated high-grade glioma 2) Receive Temozolomide maintenance therapy after standard therapy including surgery, radiotherapy, and chemotherapy with Temozolomide 3) Be at score 70 or over of Karnofsky Performance Status (KPS) 4) Be expected to survive for 2months or longer after initiation of the study therapy 5) Be at age 20 or older 6) Visit outpatient department 7) Have an adequate function of liver, kidney, and bone marrow when eligibility is confirmed 8) Provide written consent to participate this study
Exclusion criteria
Exclusion criteria: 1) Be apparent from the clinical manifestation of pulmonary fibrosis or interstitial pneumonia 2) Have a history of a serious drug allergy 3) Have a positive result of HIV or HTLV-1 antibody test 4) Have a serious cardiac disorder 5) Have an active autoimmune disorder 6) Have a cancer other than glioma 7) Have an infectious disorder that is difficult to control 8) Be a female who is pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy | — |
Secondary
| Measure | Time frame |
|---|---|
| The quality of life for patients | — |
Countries
Japan
Contacts
Juntendo University Hospital Neurosurgery