Glioblastoma
Conditions
Interventions
Experimental group:Novel oncolytic virus Ad-TD-nsIL12
Sponsors
Sanbo Brain Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with histologically proven recurrent glioblastoma; 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. Tumors must be larger than 1.0 cm in diameter; 4. Patients will consent to have a biopsy taken at the time of the stereotactic injection to confirm the presence of glioblastoma (based on frozen section) before injection of Ad-TD-nsIL-12; 5. Patients may or may not have had prior chemotherapy; 6. Patients must be willing and able to give informed consent; 7. Aged>=18 years; 8. Patients must have a Karnofsky performance status>=70; 9. Patients must have recovered from the toxic effects of prior therapy (i.e. CTC grade 1 or less). For example, they must be at least 2 weeks after vincristine, 6 weeks after nitrosoureas, and 3 weeks after procarbazine or temozolamide administration; 10. Patients with sufficient hematopoietic function of bone marrow and liver/renal function.
Exclusion criteria
Exclusion criteria: 1. Perform any radiation therapy within 4 weeks prior to AD-TD-NSIL-12 administration. 2. Uncontrolled active infection or unstable or severe infection complicating disease. All patients must be febrile at baseline. 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. Women who are pregnant and/or breastfeeding. 6. Patients with immunodeficiency, autoimmune diseases, active hepatitis B or C, or HIV positive. 7. patients with multiple intracranial primary or recurrent GBM. 8. patients with extracranial metastases. 9. Biological/immunotherapy (e.g., IL-2, IL-12, interferon) was performed within 4 weeks after administration. 10. Concurrent chemotherapy, radiotherapy or biological therapy. 11. 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. 12. White blood cell (WBC) 1.8x control. 13. Grade 4 hemotoxicity. 14. Serum creatinine > 1.5 mg/dL. 15. Liver aminotransferase (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)) or total bilirubin > 2 times the upper limit of normal. 16. Receive any type of vaccine within 30 days prior to AD-TD-NSIL-12 administration. 17. 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. 18. A history of encephalitis, multiple sclerosis, other central nervous system infections, or primary central nervous system disorders may affect the subject's evaluation. 19. Patients who have been treated with gene transfer therapy or have been treated with any type of cytolytic virus. 20. Men or women who refused contraception during the study and within 6 months after AD-TD-NSIL12 injection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival, OS;progression-free survival, PFS; | — |
Countries
China
Contacts
Public ContactHongwei Zhang
Sanbo Brain Hospital Capital Medical University
Outcome results
None listed