recurrent glioblastoma
Conditions
Interventions
Interventional group:Inject with a medium dose of 5*10^9 pfu as the starting point. The drug is given once every two weeks, for a total of four shots. Depending on the size of the tumor, the choice is
Sponsors
Mianyang Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1)Age >=18 years, =70; 5) Expected survival>=3 months; 6) Time from the last radiotherapy/surgery is more than 28 days; 7) Subjects maintained stable or declining for at least 7 days prior to corticosteroid regimen; 8) Most recent antitumor therapy must have been completed within the specified time prior to treatment: vincristine 2 weeks, nitrosoureas 4 weeks, bevacizumab 4 weeks, temozolomide 6 weeks; 9) Hematological indicators, kidney and liver function are normal; 10) The subjects must agree to the use of an acceptable contraceptive method throughout the study, from the time informed consent is provided to 180 days after receiving treatment.
Exclusion criteria
Exclusion criteria: 1) Participated in other drug clinical trials within 4 weeks; 2) Preoperative bleeding susceptibility or use of anticoagulants or any medication that may increase the risk of bleeding; 3) Patients with extracranial metastases; 4) Have poorly controlled clinical diseases, such as liver aminotransferase (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)) or total bilirubin > 2 times the upper normal limit; 5) Female subjects: during pregnancy or lactation; 6) Uncontrolled active infection, unstable or severe concomitant disease of infection. Patients with immunodeficiency, autoimmune diseases, active HBV infection, HCV infection, or active HIV infection; 7) Patients with a history of psychotropic substance abuse who are unable to quit or with mental disorders;8)Subjects had any active autoimmune disease or a history of autoimmune disease; 9) Has a history of antiviral drug use within 1 week; 10) Subjects are receiving immunosuppressive therapy, or concurrent chemotherapy, or radiation, or biotherapy; 11) There are prohibited items for MRI, such as: pacemakers, epicardial pacemaker wires, infusion pumps, surgical and/or aneurysm clips, shrapnel, metal prostheses, potentially magnetic implants, metal objects in the eye, etc.; 12) History of substance abuse or known medical, or psychological, or social conditions, such as alcohol or drug abuse; 13) Allergic, hypersensitive or intolerant to study oncolytic viruses (including any excipients); 14) Vaccination within 30 days prior to administration; 15) Patients who have received gene transfer therapy or treated with any type of oncolytic virus; 16) History of encephalitis, or multiple sclerosis, or other central nervous system (CNS) infections, or primary CNS disease; 17) Male or female patients who refused contraception during the study period and for 6 months after dosing; 18) In the investigator's judgment, there is a serious concomitant disease that endangers the patient's safety or interferes with the patient's ability to complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose; | — |
Secondary
| Measure | Time frame |
|---|---|
| lymphocyte subpopulation;cytokine(IL-12p70CXCL10IL-1a,IL-1b); | — |
Countries
China
Contacts
Public ContactLiangxue Zhou
Mianyang Central Hospital
Outcome results
None listed