A Phase 1 / 2 Dose Escalation Study of Locally-Administered OncoGel™ in Subjects With Recurrent Glioma

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.

Timeline

Start

2007-03

Primary completion

2009-10

Completion

2009-10

Outcome

Outcome not reported

Stopped (Business): “Sponsor business decision, not based on safety or efficacy data”

Drugs

Indications