malignant glioblastoma
Conditions
Interventions
Intervention Group:According to the routine surgical specifications of neurosurgery, surgical resection was performed at the site of tumor recurrence, and Ommaya capsule catheterization was performed
if the maximum diameter of the lesion is = 10 cm, inject 1.0 × 1012vp (2 vials 1ml)
if the maximum diameter of the lesion is > 10 cm, inject 1.5 × 1012vp (3 vials 1.5ml). Remove product from -20 ° C storage prior to use, melt completely at room temperature, and mix gently. Generally,
the injection rate was slow, and leakage into the ventricle or spillage into th
Sponsors
Department of Neurosurgery, Chengdu Shangjin Nanfu Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Fully informed consent and signed informed consent form, aged = 18 years old, male or female; 2) According to WHO classification criteria for central nervous system tumors, the pathological diagnosis was glioblastoma; 3) Patients failed standard treatment, including radiotherapy and temozolomide chemotherapy; 4) Patients with short-term recurrence (within 1 year) after failure of standard treatment; 5) KPS score = 70 points; 6) The diameter of tumor lesions is greater than or equal to 3.0 cm, and a single relatively closed tumor cavity is selected after surgery (excluding extracerebral metastatic lesions, multiple intracranial malignant glioma lesions, lesions located in the ventricles, brainstem, or posterior fossa, or lesions requiring intraventricular administration as well as lesions spreading to the subarachnoid layer); 7) Patients have recovered from the toxic effects of previous treatment (ie, CTC grade 1 or lower); 8) Patients must have adequate bone marrow hematopoietic function and liver and kidney function; 9) Expected survival = 3 months;
Exclusion criteria
Exclusion criteria: 1) Pregnant and/or breastfeeding women; 2) Patients with immunodeficiency, autoimmune diseases, active hepatitis B or C or HIV-positive patients; 3) Biological/immunotherapy (IL-2, IL-12, interferon) within 4 weeks; 4) There are prohibitions for MRI, such as pacemakers, epicardial pacemaker lines, infusion pumps, surgical procedures and/or aneurysm clips, shrapnel, metal prostheses, potentially magnetic implants, metal objects in the eyes, etc.; 5) White blood cell (WBC) 1.0 × control; 6) Serum creatinine > 1.5 mg/dL. Hepatic transaminases (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) or total bilirubin > 2 times the upper limit of normal); 7) History of encephalitis, multiple sclerosis, other central nervous system infections or primary central nervous system diseases, which may affect the assessment of the subject; 8) Inability to obtain informed consent due to psychiatric problems or complex medical conditions;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;Disease Control Rate;Objective Response Rate; | — |
Countries
China
Contacts
Public ContactWang Xiang
Department of Neurosurgery, Chengdu Shangjin Nanfu Hospital
Outcome results
None listed