Glioma
Conditions
Interventions
Case series:ON-01
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Patients has given written informed consent; 2) Age is between 18 years old and 75 years old, inclusive; 3) Patients must have histologically or cytologically confirmed Glioblastoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligodendrocyte-glioma; 4) Residual lesion must be =1.0 cm in diameter as determined by MRI; 5) Karnofsky Performance Status =70%; 6) Patients must have normal organ and marrow function. Absolute neutrophil count: = 1,500/mm3, Hemoglobin>10 g/dL platelets: >100,000/mm3, total bilirubin< 1.5 ×ULN; AST(SGOT)(aspartate aminotransferase)/ALT(SGPT)(alanine aminotransferase): <2.5 X institutional upper limit of normal; Serum creatinine < 1.5 ×ULN, and normal heart function; 7) Good compliance: can actively cooperate with doctors' treatment and follow-up survey; 8) Females of childbearing potential must not be pregnant; this will be confirmed by a negative serum pregnancy test within 7 days prior to starting study treatment and must use a birth control method in addition to barrier methods (condoms).
Exclusion criteria
Exclusion criteria: 1) Pregnant or lactating women; 2) Prior history of encephalitis, multiple sclerosis, or other CNS infection; 3) Herpes simplex virus infection active period; 4) Patients with a history of organ transplantation or waiting for an organ transplant; 5) Uncontrollable infectious diseases or other serious diseases such as HIV positive; 6) Severe pulmonary, cardiac or other systemic disease, specifically: Including active infections, uncontrolled high blood pressure, unstable angina pectoris, angina pectoris that began to develop within the last 3 months, congestive heart failure, myocardial infarction that occurred within the first 12 months of enrollment, requiring serious;medical treatment Arrhythmia, liver, kidney failure, etc.; 7) Patients with systemic autoimmune disease or immunodeficiency disease; 8) Patients with severe allergies; 9) Patients with chronic diseases requiring long-term immunologic preparation or glucocorticoid therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival;Overall survival;Ratio of PFS;Time to Progression;Objective response rate; | — |
Countries
China
Contacts
Public ContactFusheng Liu
Beijing Neurosurgical Institute
Outcome results
None listed