High grade glioma
Conditions
Interventions
cohort 1:novel Oncolytic Adenovirus of Ad-TD-nsIL12 injection 1x10^10vp every time (twice)
cohort 2:novel Oncolytic Adenovirus of Ad-TD-nsIL12 injection 5x10^10vp every time (twice)
cohort 3:novel Oncolytic Adenovirus of Ad-TD-nsIL12 injection 2.5x10^11vp every time (twice)
Sponsors
Sanbo Brain Hospital, Capital Medical University, Beijing 100093
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with histologically proven recurrent high grade glioma; 2. Patients must show unequivocal evidence for tumor recurrence or progression by MRI scan after failing prior surgical resection, biopsy, chemotherapy or radiation. A baseline MRI must be performed within 15 days prior to Day 0/Baseline.; 3.Patients will consent to have a biopsy or surgery taken at the time of injection to confirm the presence of high grade glioma (based on frozen section or conventional histopathological) before injection of Ad-TD-nsIL-12; 4. Patients will consent to implant Ommaya reservoir. 5. Patients must be willing and able to give informed consent; 6. Aged>=18 years and =60; 8. Patients with sufficient hematopoietic function of bone marrow and liver/renal function.
Exclusion criteria
Exclusion criteria: 1. Uncontrolled active infection or unstable or severe infection complicating disease. All patients must be febrile at baseline. 2. No direct communication between the tumor cavity and the ventricles 3. Predisposition to bleeding or use of anticoagulants or any medication that may increase the risk of bleeding before surgery. Patients may be eligible if, in the surgeon's clinical judgment, AD-TD-NSIL-12 can be discontinued prior to injection. 4. Failure to obtain informed consent due to psychiatric problems or complex medical conditions. 5. Patients with immunodeficiency, autoimmune diseases, active hepatitis B or C, or HIV positive. 6.Presence of prohibited items for MRI examination, 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. 7. White blood cell (WBC) 1.8x control. 8. Serum creatinine > 1.5 mg/dL. 9. Liver aminotransferase (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)) or total bilirubin > 2 times the upper limit of normal. 10. Receive any type of vaccine within 30 days prior to AD-TD-NSIL-12 administration. 11. Patients with a current diagnosis of other cancers, other than cured cervical cancer in situ, basal or squamous cell carcinoma of the skin, and a previous history of another cancer that has been absent for at least three years remain eligible. 12. A history of encephalitis, multiple sclerosis, other central nervous system infections, or primary central nervous system disorders may affect the subject's evaluation. 13.A history of encephalitis, multiple sclerosis, other central nervous system infections, or primary central nervous system disorders may affect the subject's evaluation. 14. Women who are pregnant and/or breastfeeding. 15. Men or women who refused contraception during the study and within 6 months after AD-TD-NSIL12 injection. 16.Other factors judged by researchers do not meet the inclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse event(AE); | — |
Secondary
| Measure | Time frame |
|---|---|
| Maximum tolerable dose; | — |
Countries
China
Contacts
Public ContactZhang Hongwei
Department of Neurosurgery, Sanbo Brain Hospital, Capital Medical University, Beijing 100093
Outcome results
None listed