Actively Recruiting
Oncolytic Virus Ad-TD-nsIL12 for Progressive Pediatric Diffuse Intrinsic Pontine Glioma
Led by Capital Medical University · Updated on 2024-02-28
18
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-arm, single-center, drug safety assessment clinical trial with a 3+3 dose escalation design, to observe the safety, tolerability and toxicity of a novel oncolytic virus Ad-TD-nsIL12 intratumoral injection in progressive DIPG patients (NCI-CTCAE V5.0).
CONDITIONS
Official Title
Oncolytic Virus Ad-TD-nsIL12 for Progressive Pediatric Diffuse Intrinsic Pontine Glioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Parents or patient have given informed consent
- Tumor progression confirmed by MRI after surgery, biopsy, chemotherapy, or radiation
- Biopsy performed before Ad-TD-nsIL12 injection confirming DIPG
- Patients aged 1 to 18 years
- Pre-enrollment life performance score (LPS for ages 1 to <16 years or KPS for ages 616 years) 65
- Patient can follow all study procedures as judged by the investigator
- Negative pregnancy test for women of childbearing potential
- Lesion accessible for stereotactic biopsy as judged by the investigator
You will not qualify if you...
- Serious infections or severe organ failures such as kidney, liver, heart, or bone marrow failure; patient must be afebrile (<38C) at viral therapy time
- Use of other investigational medications within 30 days before viral treatment
- Immunodeficiency, autoimmune disease, or active hepatitis
- Medical or psychological conditions interfering with participation or consent
- Tumor located in multiple sites
- Pregnant or breastfeeding females
- Severe bone marrow hypoplasia
- Elevated liver enzymes or bilirubin more than 3 times the normal limit
- Neutrophils below 1x10^9/L
- Platelet count less than or equal to 100x10^9/L
- Hemoglobin less than 9 g/dl
- Known Li-Fraumeni syndrome or germline retinoblastoma gene defects
- Vaccination within 30 days prior to viral treatment
- Blood transfusions or drugs like G-CSF within 28 days prior to treatment to manage blood disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sanbo Brain Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100010
Actively Recruiting
Research Team
X
Xiao Qian, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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