Injected oncolytic virus for recurrent glioblastoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1/2 interventional study gives an oncolytic viral agent directly into recurrent glioblastoma tumors via intratumoral injection, with up to six injections spaced every 2–4 weeks. Participants will have regular physical exams, blood tests, and brain imaging every 2–4 weeks to monitor safety, tolerability, and any tumor response. Eligible patients are adults (18–70) with histologically confirmed recurrent GBM and lesions larger than 1.0 cm who have exhausted standard treatment options and have adequate organ function. The trial is conducted at a single center (Mianyang Central Hospital) and focuses primarily on safety while collecting preliminary efficacy data.

Why it matters

Who can join: the full rules

Inclusion criteria:

1. Patients with recurrent glioblastoma, for whom the standard methods of treatment are considered ineffective by the medical commission.
2. Histologically confirmed recurrent glioblastoma.
3. Magnetic resonance imaging (MRI) showed that the maximum diameter of recurrent lesions is greater than 1.0 cm.
4. Before inclusion of patients in the study, at least one of the following types of therapy was previously performed: 4.1 Time from the last radiotherapy/surgery is more than 28 days; 4.2 Subjects maintained stable or declining for at least 7 days prior to corticosteroid regimen; 4.3 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.
5. Age \>=18 years, \<=70 years.
6. Hematological indicators, kidney and liver function are normal.
7. 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.
8. Patient's ability to perform the study procedure and provide written informed consent in accordance with the GCP and local laws.

Exclusion criteria:

1. Incompatibility of patients with the inclusion criteria mentioned above.
2. Participated in other drug clinical trials within 4 weeks
3. Preoperative bleeding susceptibility or use of anticoagulants or any medication that may increase the risk of bleeding.
4. Patients with extracranial metastases.
5. 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.
6. Female subjects: during pregnancy or lactation.
7. Uncontrolled active infection, unstable or severe concomitant disease of infection. Patients with immunodeficiency, autoimmune diseases, active HBV infection, HCV infection, or active HIV infection.
8. Patients with a history of psychotropic substance abuse who are unable to quit or with mental disorders.
9. Subjects had any active autoimmune disease or a history of autoimmune disease.
10. Has a history of antiviral drug use within 1 week.
11. Subjects are receiving immunosuppressive therapy, or concurrent chemotherapy, or radiation, or biotherapy.
12. 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..
13. History of substance abuse or known medical, or psychological, or social conditions, such as alcohol or drug abuse.
14. Allergic, hypersensitive or intolerant to study oncolytic viruses (including any excipients).
15. Vaccination within 30 days prior to administration.
16. Patients who have received gene transfer therapy or treated with any type of oncolytic virus.
17. History of encephalitis, or multiple sclerosis, or other central nervous system (CNS) infections, or primary CNS disease.
18. Male or female patients who refused contraception during the study period and for 6 months after dosing.
19. 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.

Where it's running

• Mianyang Central Hospital
  Mianyang, Sichuan, China Recruiting

Study contacts

• Study coordinator: Liang xue Zhou
• Email: liangxue_zhou@126.com
• Phone: +868162247827

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.