Actively Recruiting
Oncolytic Virus Ad-TD-nsIL12 for Primary 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 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 primary DIPG patients (NCI-CTCAE V5.0).
CONDITIONS
Official Title
Oncolytic Virus Ad-TD-nsIL12 for Primary Pediatric Diffuse Intrinsic Pontine Glioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Parents or patient have provided informed consent
- Patient is able to follow all study procedures according to the investigator
- Age between 1 and 18 years
- Negative pregnancy test for females of childbearing potential
- Newly diagnosed with DIPG confirmed by MRI
- Pre-enrollment Lansky Performance Score (LPS) or Karnofsky Performance Score (KPS) of 50 or higher
- Lesion accessible for stereotactic biopsy without virus entering the ventricular system
- No prior treatment for DIPG
You will not qualify if you...
- Serious infections or severe organ failure, including kidney, liver, heart, or bone marrow failure
- Fever at baseline (temperature 38°C or higher)
- Use of other investigational drugs within 30 days before treatment
- Immunodeficiency, autoimmune disease, or active hepatitis
- Medical or psychological conditions interfering with participation or consent
- Tumor with multiple locations
- Pregnancy or breast-feeding
- Severe bone marrow hypoplasia
- Elevated liver enzymes or bilirubin more than 3 times normal
- Low neutrophil count (<1x10^9/L)
- Low platelet count (≤100x10^9/L)
- Low hemoglobin (<9 g/dl)
- Diagnosis of Li-Fraumeni syndrome or known germline retinoblastoma gene defect
- Vaccination within 30 days before treatment
- Blood transfusions or blood disorder treatments within 28 days before baseline
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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