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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
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.
Sanbo Brain Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGSafety of Ad-TD-nsIL12 intratumoral injection in progressive 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 injection
Tumor response
To determine tumor response by RAPNO criteria
Time frame: 3 months after virus injection
Over-all survival
To determine overall survival at 12 months (OS12).
Time frame: 12 months after virus injection
QoL
To measure quality of life baseline assessment and any changes over time by PedsQLTM criteria.
Time frame: 2 years after virus injection
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 injection
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.