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

Launched by CAPITAL MEDICAL UNIVERSITY · Jan 29, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Ad-TD-nsIL12, which is an oncolytic virus designed to target and help fight a type of brain tumor known as Diffuse Intrinsic Pontine Glioma (DIPG) in children. The main goal is to assess how safe this treatment is for patients with progressive DIPG after they have undergone other therapies like surgery, chemotherapy, or radiation. The trial is currently recruiting participants aged 1 to 18 years, who have shown evidence of tumor progression confirmed by MRI scans. Parents or guardians will need to provide consent for their children to participate.

Eligible participants will receive the virus through an injection directly into the tumor, and the study is monitoring for any side effects or complications from this treatment. It’s important to note that certain health conditions, such as serious infections or severe organ failures, may prevent someone from joining the trial. Additionally, the trial has specific guidelines regarding recent treatments and medications that participants must follow. Overall, this trial aims to explore a new way to treat a challenging condition while ensuring the safety and well-being of young patients.

Gender

ALL

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.