Using a virus to treat pediatric brain tumors

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

This study is testing a new virus treatment for children with a tough brain tumor called DIPG to see if it is safe and how much of it can be given.

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)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT05717712 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 diagnosed with diffuse intrinsic pontine glioma (DIPG). The study employs a 3+3 dose escalation design to assess adverse drug events and determine the appropriate dosage for future treatments. Participants will be closely monitored for any toxicity or side effects associated with the treatment. The trial aims to provide a new therapeutic option for this challenging pediatric brain tumor.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 1-18 years who have been newly diagnosed with DIPG and meet specific health criteria.

Not a fit: Patients with serious infections or significant organ failures, as well as those who have previously received treatment for DIPG, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new, effective option for children suffering from DIPG, potentially improving survival rates and quality of life.

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

Eligibility criteria

Inclusion Criteria:

1. Informed consent of the parents or patient.
2. Patient must be, in the investigator opinion, able to comply with all the protocol procedures.
3. Age 1-18 years.
4. 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).
5. Patient newly diagnosed of DIPG in MRI.
6. Pre-enrollment patients LPS (patients aged ≥1 and \<16 years) and KPS (patients aged ≥16 years) ≥ 50.
7. Lesion considered by the investigator to be accessible for stereotactic biopsy. The location of the lesion allows injection without virus entering the ventricular system.
8. No previous treatment for DIPG.

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 at baseline (\<38℃).
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 \< 9 g/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 baseline to treat pancytopenia or other blood 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