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Trial Title:
Oncolytic Virus Ad-TD-nsIL12 for Progressive Pediatric Diffuse Intrinsic Pontine Glioma
NCT ID:
NCT05717699
Condition:
Oncolytic Virus
Diffuse Intrinsic Pontine Glioma
Adverse Drug Event
Conditions: Official terms:
Glioma
Diffuse Intrinsic Pontine Glioma
Drug-Related Side Effects and Adverse Reactions
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Ad-TD-nsIL12
Description:
After stereotactic biopsy, the Ommaya reservoir will be inserted through the biopsy
channel and two injections of Ad-TD-nsIL12 will be delivered after surgery by Ommaya
reservoir (with an interval of 3days). The interval between following injections in the
subsequent treatment period will be 3 weeks ±4 days. The assigned dose for each patient
will be 3x10^9vp, 1x10^10vp or 3x10^10 vp suspended in 1 ml NS according to cohort
design.
Arm group label:
Experimental Group
Summary:
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).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Informed consent of the parents or patient.
2. After surgical resection, biopsy, chemotherapy, or radiation therapy, tumor
progression must be confirmed by MRI scan.
3. Biopsy is performed prior to injection of Ad-TD-nsIL12 to confirm DIPG (frozen
section-based).
4. Pre-enrollment patients LPS (patients aged ≥1 and <16 years) and KPS (patients aged
≥16 years) ≥ 50.
5. Patient must be, in the investigator opinion, able to comply with all the protocol
procedures.
6. Age 1-18 years.
7. 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).
8. Lesion considered by the investigator to be accessible for stereotactic biopsy.
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 (<38℃) at the time of viral therapy.
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 < 9g/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 viral treatment to
treat pancytopenia or other hematological disorders.
Gender:
All
Minimum age:
1 Year
Maximum age:
18 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sanbo Brain Hospital, Capital Medical University
Address:
City:
Beijing
Zip:
100010
Country:
China
Status:
Recruiting
Contact:
Last name:
Weihai Ning, Dr.
Phone:
+86 15961868172
Email:
sanboocean@163.com
Start date:
January 4, 2023
Completion date:
January 4, 2028
Lead sponsor:
Agency:
Capital Medical University
Agency class:
Other
Source:
Capital Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05717699
