Study design and participants
toxicity, glioblastoma, CED, tumor
GLIOBLASTOMA, TUMOR
This was a prospective, international, multi-center, open-label, Phase 1 dose escalation trial on recurrent glioblastoma patients, evaluating safety and feasibility of hrBMP4 administered through convection enhanced delivery (CED). Secondary objectives were to assess systemic exposure to hrBMP4 upon intracerebral delivery and its efficacy. To achieve maximum tumor cell exposure and minimal systemic toxicity, hrBMP4 was administered intratumorally and intraparenchymally by CED. Since liquids spread poorly within glioblastoma, this technique consists of a slow continuous infusion with a positive pressure gradient, allowing hrBMP4 to better reach the tumor [