A Tumor-Targeted Replicating Oncolytic Adenovirus Ad-TD-nsIL12 as a Promising Therapeutic Agent for Human Esophageal Squamous Cell Carcinoma.
Zifang Zhang, Chunyang Zhang, Jinxin Miao...
https://pubmed.ncbi.nlm.nih.gov/33182528Actively Recruiting
Phase 1
Age: 1Year - 18Years
All Genders
ID05717712
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
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and toxicity of a new oncolytic virus called Ad-TD-nsIL12, given by injection into tumors, for children aged 1 to 18 years with newly diagnosed diffuse intrinsic pontine glioma (DIPG). This early phase 1 clinical trial uses a dose escalation design to observe how patients respond to the virus treatment according to standard safety criteria (NCI-CTCAE V5.0). Participants will receive multiple intratumoral injections of Ad-TD-nsIL12 after undergoing a stereotactic biopsy and placement of an Ommaya reservoir through the biopsy channel. Two injections are given shortly after surgery, spaced 3 days apart, followed by additional injections every 3 weeks plus or minus 4 days. The virus doses vary based on patient cohorts, ranging from 3x10^9 to 3x10^10 viral particles suspended in 1 ml saline. During the trial, patients will be monitored closely with safety assessments at 3 months after the virus injection. Researchers will also evaluate tumor response at 3 months, overall survival at 12 months, and quality of life over 2 years. Sample collections will occur at 3 months to support these evaluations. This study is led by Capital Medical University and runs until 2028, focusing on careful observation of patients throughout the course of treatment and follow-up.
CONDITIONS
Brief Title
Oncolytic Virus Ad-TD-nsIL12 for Primary Pediatric Diffuse Intrinsic Pontine Glioma
Who Can Participate
Age: 1Year - 18Years
All Genders
Eligibility Criteria
You may qualify if you...
- Informed consent provided by parents or patient
- Ability to comply with all protocol procedures as judged by the investigator
- Age between 1 and 18 years
- Negative pregnancy test for women of childbearing potential
- Newly diagnosed DIPG confirmed by MRI
- Lansky Performance Status (LPS) or Karnofsky Performance Status (KPS) score 50 depending on age
- Tumor lesion accessible for stereotactic biopsy and suitable for injection without risk to ventricular system
- No prior treatment for DIPG
You will not qualify if you...
- Serious infections or organ failures such as severe renal, liver, heart, or bone marrow failure
- Fever above 386C at baseline
- Use of other investigational medications within 30 days before treatment
- Immunodeficiency, autoimmune disease, or active hepatitis
- Medical or psychological conditions affecting participation or consent
- Tumors with multiple locations
- Pregnancy or breastfeeding
- Severe bone marrow hypoplasia
- Elevated liver enzymes or bilirubin over 3 times normal limit
- Low neutrophil count (<1x10^9/L)
- Low platelets ( 100x10^9/L)
- Hemoglobin less than 9 g/dl
- Known Li-Fraumeni syndrome or germline defects in retinoblastoma gene pathways
- Vaccination within 30 days before virus administration
- Blood transfusions or treatments for blood disorders within 28 days before baseline
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Initial injections with a 3-day interval followed by subsequent injections every 3 weeks ±4 days
Participants receive multiple intratumoral injections of the oncolytic virus Ad-TD-nsIL12 through an Ommaya reservoir inserted after stereotactic biopsy.
2 injections within first week and additional injections every 3 weeks
Follow-up
Duration - Up to 2 years after virus injection
Participants are monitored for safety, tumor response, overall survival, quality of life, and sample collection after completing treatment.
Visits at 3 months, 12 months, and 2 years post-injection
Trial Site Locations
Total: 1 location
1
Sanbo Brain Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100010
Actively Recruiting
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Research Team
X
Xiao Qian, Dr.
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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Published Research Related To This Trial
Treatment of pancreatic cancer with an oncolytic adenovirus expressing interleukin-12 in Syrian hamsters.
Sergia Bortolanza, Maria Bunuales, Itziar Otano...
https://pubmed.ncbi.nlm.nih.gov/19223865Re-designing Interleukin-12 to enhance its safety and potential as an anti-tumor immunotherapeutic agent.
Pengju Wang, Xiaozhu Li, Jiwei Wang...
https://pubmed.ncbi.nlm.nih.gov/29123084