Using a virus to treat progressive pediatric brain tumors

Oncolytic Virus Ad-TD-nsIL12 for Progressive Pediatric Diffuse Intrinsic Pontine Glioma

This study is testing a new virus treatment for children with a serious brain tumor called DIPG to see if it's safe to use after other treatments like surgery and chemotherapy.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 1 Year to 18 Years
• Sex: All
• Sponsor: Capital Medical University (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT05717699 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and tolerability of a novel oncolytic virus, Ad-TD-nsIL12, administered through intratumoral injection in children with progressive Diffuse Intrinsic Pontine Glioma (DIPG). It employs a single-arm, single-center design with a 3+3 dose escalation approach to assess potential adverse effects and toxicity. The study aims to confirm the safety profile of this innovative treatment following standard therapies like surgery and chemotherapy. Participants will undergo MRI scans to confirm tumor progression before treatment.

Who should consider this trial

Good fit: Ideal candidates are children aged 1 to 18 years with confirmed progressive DIPG after prior treatments.

Not a fit: Patients with serious infections or significant organ failures may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for children suffering from a highly aggressive brain tumor.

How similar studies have performed: While oncolytic virus therapies are an emerging field, this specific approach is novel and has not been extensively tested in similar pediatric populations.

Eligibility criteria

Inclusion Criteria:

1. Informed consent of the parents or patient.
2. After surgical resection, biopsy, chemotherapy, or radiation therapy, tumor progression must be confirmed by MRI scan.
3. Biopsy is performed prior to injection of Ad-TD-nsIL12 to confirm DIPG (frozen section-based).
4. Pre-enrollment patients LPS (patients aged ≥1 and \<16 years) and KPS (patients aged ≥16 years) ≥ 50.
5. Patient must be, in the investigator opinion, able to comply with all the protocol procedures.
6. Age 1-18 years.
7. A negative pregnancy test in fertile women (women are considered of childbearing potential (WOCBP) after menarche, unless permanently infertile, including hysterectomy, bilateral salpingectomy, and bilateral oophorectomy).
8. Lesion considered by the investigator to be accessible for stereotactic biopsy.

Exclusion Criteria:

1. Serious infections or intercurrent conditions, including but not limited to severe renal failure, liver failure, heart failure, or bone marrow failure, which are not permitted for inclusion according to the investigator's criteria. Patients must be afebrile (\<38℃) at the time of viral therapy.
2. Other investigational medications within 30 days prior to viral treatment.
3. Participants with immunodeficiency, autoimmune disease, or active hepatitis.
4. Any medical or psychological condition that might interfere with the patient's ability to participate if older than 16 years or parents ability when younger than 16, or give informed consent or would compromise the patient's ability to tolerate therapy or any disease that will obscure toxicity or dangerously alter drug metabolism.
5. Tumor with multiple location.
6. Pregnant or breast-feeding females.
7. Severe bone marrow hypoplasia.
8. Transaminases (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)) or total bilirubin \> 3 times the upper limit of normal.
9. Neutrophils \< 1x10\^9/L.
10. Platelets ≤ 100x10\^9/L.
11. Hemoglobin \< 9g/dl.
12. Patients with Li-Fraumini syndrome or a known germline defect in the retinoblastoma gene or its associated pathways.
13. Administer any type of vaccine within 30 days prior to Ad-TD-nsIL12 administration.
14. Blood transfusions or drugs (such as G-CSF) within 28 days before viral treatment to treat pancytopenia or other hematological disorders.

Where this trial is running

Beijing, Beijing Municipality

• Sanbo Brain Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Hongwei Zhang, Prof. — Capital Medical University
• Study coordinator: Xiao Qian, Dr.

Conditions Oncolytic Virus; Diffuse Intrinsic Pontine Glioma; Adverse Drug Event