Oncolytic Virus Ad-TD-nsIL12 for Primary 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 delivered directly into tumors using a special virus. The goal is to see how safe this treatment is for children with a type of brain cancer known as Diffuse Intrinsic Pontine Glioma (DIPG). The study is currently looking for participants who are between 1 and 18 years old, have recently been diagnosed with DIPG, and have not received any prior treatments for their condition. Parents or guardians will need to provide consent for their child to join the study.

If your child qualifies and decides to participate, they will receive this treatment through an injection into the tumor. The researchers will closely monitor how well your child tolerates the treatment and any potential side effects that may arise. It's important to know that certain health conditions, recent treatments, or medications might make some children ineligible to participate. The trial aims to help improve future treatments for DIPG, a challenging condition, and your child's involvement could contribute valuable information to this important research.

Gender

ALL

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.