Phase 1 Trial of Engineered HSV G207 Virus Therapy With or Without Low-Dose Radiation for Children and Young Adults Ages 3 to 21 With Recurrent or Refractory Cerebellar Brain Tumors

What this Trial Is About

Researchers are investigating the safety of G207, an engineered herpes simplex virus-1 HSV-1 therapy, for children and young adults aged 3 to 21 with recurrent or progressive malignant cerebellar brain tumors. These tumors have poor outcomes after standard treatments fail. The study also evaluates combining G207 with a single low dose of radiation to enhance virus replication, tumor cell killing, and trigger an anti-tumor immune response. Participants receive a single dose of G207 infused directly into the tumor through catheters. If the initial safety is confirmed, subsequent groups will receive G207 followed by a 5 Gy radiation dose to active tumor areas within 24 hours to increase treatment effect. This phase I, open-label trial uses a traditional 3 3 design with four patient cohorts, starting with G207 alone and progressing to combined therapy. During the study, participants undergo MRI reviews to confirm tumor size and location suitable for treatment. Researchers monitor safety by tracking adverse events for up to 15 years, along with immune response, virus shedding, progression-free survival, overall survival, performance ability, and optional quality of life assessments. The trial involves careful evaluation of laboratory tests, performance scores, and long-term follow-up to understand treatment tolerability and preliminary effectiveness.

HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors