Malignant Glioma
Conditions
Interventions
Experimental group:Intratumoral Injection of Oncolytic Virus
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Intraoperative biopsy pathology examination must confirm the presence of malignant glioma (WHO grade 3-4). If the subject has previously been diagnosed with a low-grade glioma, the biopsy must show that the lesion has progressed to a high-grade glioma; 2. Subjects must have a previously diagnosed glioma (astrocytoma, malignant astrocytoma, oligodendroglioma, anaplastic oligodendroglioma, mixed oligoastrocytoma), but exclude ependymoma, ganglioglioma, and pyloric glioma/pyloric myxoid astrocytoma confirmed by a neuropathologist or previous pathology report; 3. The recurrence lesions must be confirmed by magnetic resonance imaging (MRI) with a maximum diameter greater than 1.0 cm and less than 3.0 cm; 4. The tumor must be located at a site suitable for stereotactic injection; 5. KPS score >= 70; 6. Age must be greater than 18 years; 7. Must be able to understand and voluntarily sign an informed consent form; 8. Hematological indicators, kidney, and liver functions must be normal; 9. The subject's last anti-tumor treatment must have been completed within the specified time before treatment: Vincristine 2 weeks, Nitrosourea 4 weeks, Bevacizumab 4 weeks; 10. The subject’s corticosteroid treatment regimen must have been stable or declining for at least 7 days prior to injection; 11. Requirements for reproductive-aged subjects: (1) Female subjects with non-fertility must provide evidence of their non-fertility, such as continuous amenorrhea for more than 2 years, undergoing hysterectomy or bilateral oophorectomy, etc., and pre-menopausal assessment confirming menopause. Such subjects may be exempt from pregnancy testing or contraception; (2) Female subjects with fertility potential must have a negative urine or serum pregnancy test within 24 hours prior to receiving treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test is required to confirm a negative result. For eligible subjects, the serum pregnancy test must be negative; (3) Female subjects with fertility potential must be willing to use two highly effective contraceptive methods throughout the study, starting from 180 days after receiving treatment and providing informed consent; (4) Throughout the study, male subjects must agree to use an acceptable contraceptive method, from the time informed consent is provided up to 180 days after receiving treatment.
Exclusion criteria
Exclusion criteria: 1. Any radiotherapy within 4 weeks before treatment; 2. Uncontrolled active infections or unstable or severe infectious complications. All patients must be afebrile at baseline; 3. Preoperative bleeding susceptibility or use of anticoagulants or any drugs that may increase bleeding risk. If, in the clinical judgment of the surgeon, medication can be discontinued before administration, then the patient may be eligible; 4. Unable to obtain informed consent due to mental issues or complex medical conditions; 5. Pregnant and/or breastfeeding women; 6. Patients with immune deficiency, autoimmune diseases, active hepatitis B or C, or HIV positive patients; 7. Patients with extracranial metastasis; 8. Biological/immunotherapy (e.g., IL-2, IL-12, interferon) within 4 weeks after administration; 9. Concurrent chemotherapy, radiotherapy, or biological therapy; 10. Presence of contraindications for magnetic resonance imaging, such as: pacemakers, epicardial pacing wires, infusion pumps, surgical clips and/or aneurysm clips, shrapnel, metallic prostheses, potentially magnetic implants, metallic objects in the eyes, etc.; 11. White blood cell (WBC) 1.8 times normal; 12. Grade 4 hematologic toxicity; 13. Serum creatinine > 1.5 mg/dL; 14. Liver transaminases (aspartate transaminase (AST) and/or alanine transaminase (ALT)) or total bilirubin > 2 times the normal upper limit; 15. Vaccination of any kind within 30 days prior to administration; 16. Currently diagnosed with other cancers, excluding cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin. Patients with a history of another cancer but with no evidence for at least three years are still eligible; 17. History of encephalitis, multiple sclerosis, other central nervous system infections, or primary central nervous system disease that may affect the subject’s assessment; 18. Patients who have received gene transfer therapy or any type of oncolytic virus therapy; 19. Male or female subjects who refuse contraception during the study and for 6 months after administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PET-CT;Cytokine;Antibody Titer;liver fuction;kidney fuction;blood pressure;intracranial pressure;body temperature;Brain enhanced MRI; | — |
Countries
China
Contacts
Public ContactLiangxue Zhou
Neurosurgery Department, West China Hospital, Sichuan University
Outcome results
None listed