A Study of Ad-RTS-hIL-12 + Veledimex in Pediatric Subjects With Brain Tumors Including DIPG

Inclusion criteria

• ✓. Male or female subjects ≤ 21 years-of-age with the demonstrated ability to swallow capsules whole and who are willing to provide access to previously obtained biopsy results
• ✓. Provision of written informed consent and assent, when applicable, for tumor resection, stereotactic surgery, tumor biopsy, sample collection, and/or treatment with study drug prior to undergoing any study-specific procedures
• ✓. Arm 1: Evidence of recurrent or progressive supratentorial tumor, which has shown a \> 25% increase in bi dimensional measurements by MRI or is refractory with significant neuro deterioration that is not otherwise explained with no known curative therapy, not in direct continuity with the ventricular system (e.g., there is physical separation between the tumor and ventricle, the tumor does not open directly into the ventricular system).
• ✓. At the time of registration, subjects must have recovered from the toxic effects of previous treatments, as determined by the treating physician.
• ✓. Targeted agents, including small-molecular tyrosine kinase inhibitors: 2 weeks
• ✓. Other cytotoxic agents: 3 weeks
• ✓. Nitrosoureas: 6 weeks
• ✓. Monoclonal antibody immunotherapies (eg, PD-1, CTLA-4): 6 weeks