Oncolytic Virus Ad-TD-nsIL12 for Primary Pediatric Diffuse Intrinsic Pontine Glioma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age1-18
SponsorCapital Medical University
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Informed consent of the parents or patient.
Patient must be, in the investigator opinion, able to comply with all the protocol procedures.
Age 1-18 years.
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).
Disqualifiers
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 at baseline (<38℃).
Other investigational medications within 30 days prior to viral treatment.
Participants with immunodeficiency, autoimmune disease, or active hepatitis.
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.
Trial design
Design model
Single group
Treatments tested in this trial
Ad-TD-nsIL12
Biological/VaccineAfter 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 3 days). 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.
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: Experimental GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety of Ad-TD-nsIL12 intratumoral injection in primary pediatric DIPG patients.
The trial will look for possible hematologic and neurologic toxicity of Ad-TD-nsIL12 by NCI-CTCAE v5.0 to determine maximum tolerated dose of this oncolytic adenovirus.
Time frame
3 months after virus injectionSecondary outcomes
1
Tumor response
To determine tumor response by RAPNO criteria.
Time frame
3 months after virus injection2
Over-all survival (12 months)
To determine overall survival at 12 months (OS12).
Time frame
12 months after virus injection3
QoL
To measure quality of life baseline assessment and any changes over time by PedsQLTM criteria.
Time frame
2 years after virus injection4
Sample Collection
Pre- and post- treatment tumor tissue will be collected and tested to determine the immune response of patients. Collected blood will be used to test possible hematotoxicity of Ad-TD-nsIL12.
Time frame
3 months after virus injectionSponsors and contacts
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Source ClinicalTrials.gov