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
ID05717699
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
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and side effects of a new oncolytic virus called Ad-TD-nsIL12 given as an injection directly into tumors in children aged 1 to 18 with progressive diffuse intrinsic pontine glioma (DIPG), a serious brain tumor. This early-phase trial uses a dose-escalation method to carefully observe how patients respond to the virus treatment. The study is led by Capital Medical University and focuses on progressive pediatric DIPG confirmed by biopsy and MRI scans. Participants receive multiple injections of Ad-TD-nsIL12 through an Ommaya reservoir inserted during a stereotactic biopsy. Two initial injections are given three days apart after surgery, followed by additional injections every three weeks, with some flexibility in timing. Doses vary by patient group and range from 3x10^9 to 3x10^10 viral particles suspended in 1 ml of normal saline. The treatment is delivered directly into the tumor site to assess local effects and safety. During the study, patients will be closely monitored with MRI scans to confirm tumor progression and biopsies to verify diagnosis. Safety and side effects will be tracked for three months after the virus injections. Additional assessments include tumor response at three months, overall survival at 12 months, quality of life up to two years, and collection of samples for further study. The total duration of observation extends up to two years to evaluate long-term outcomes and safety.
CONDITIONS
Brief Title
Oncolytic Virus Ad-TD-nsIL12 for Progressive Pediatric Diffuse Intrinsic Pontine Glioma
Who Can Participate
Age: 1Year - 18Years
All Genders
Eligibility Criteria
You may qualify if you...
- Informed consent of the parents or patient.
- Tumor progression confirmed by MRI after surgery, biopsy, chemotherapy, or radiation.
- Biopsy performed before Ad-TD-nsIL12 injection to confirm DIPG.
- Pre-enrollment LPS (for patients aged 1 and <16 years) or KPS (for patients aged 16 years) score 50.
- Ability to comply with all protocol procedures.
- Age between 1 and 18 years.
- Negative pregnancy test in fertile females.
- Lesion accessible for stereotactic biopsy as judged by the investigator.
You will not qualify if you...
- Serious infections or severe organ failures such as renal, liver, heart, or bone marrow failure; patient must be afebrile (<38 ).
- Use of other investigational medications within 30 days prior to viral treatment.
- Immunodeficiency, autoimmune disease, or active hepatitis.
- Medical or psychological conditions interfering with participation or consent.
- Tumors located in multiple sites.
- Pregnant or breast-feeding females.
- Severe bone marrow hypoplasia.
- Elevated liver enzymes or bilirubin more than 3 times the upper limit.
- Neutrophils less than 1x10^9/L.
- Platelets less than or equal to 100x10^9/L.
- Hemoglobin less than 9 g/dl.
- Li-Fraumini syndrome or known germline defects related to retinoblastoma gene.
- Vaccination within 30 days before Ad-TD-nsIL12 administration.
- Blood transfusions or drugs for hematological disorders within 28 days before treatment.
AI-Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - 3 months
Participants receive multiple intratumoral injections of Ad-TD-nsIL12 after stereotactic biopsy and Ommaya reservoir insertion. Two injections occur shortly after surgery with a 3-day interval, followed by additional injections every 3 weeks ±4 days during the treatment period.
Multiple visits including initial post-surgery injections and subsequent injections every 3 weeks ±4 days
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
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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