A Phase 1 / 2 Dose Escalation Study of Locally-Administered OncoGel™ in Subjects With Recurrent Glioma
Status:
Terminated
Trial end date:
2009-10-01
Target enrollment:
Participant gender:
Summary
OncoGel™ is a new, experimental drug delivery system that allows the slow continuous release
of paclitaxel (an approved intravenous anticancer drug), from a gel (ReGel™) over a long
period of time. The gel will disappear in 4 to 6 weeks as it releases the paclitaxel.
The purpose of this study is to evaluate the safety and tolerability of OncoGel when placed
into the tumor resection cavity in the brain following surgical removal of the tumor. Dose
escalation is conducted by gradually increasing the amount of OncoGel placed in the resection
cavity in small groups of patients, and watching the patients closely for side effects before
moving to the next dose level. The study will also test whether OncoGel helps to prevent or
delay the tumor from regrowing.