The study was led by Ronald Warnick, chairman of the Mayfield Clinic and professor of neurosurgery at the University of Cincinnati. The study is claimed to be the first study ever conducted to evaluate the effect of these two novel agents used simultaneously in combination with surgery to treat recurrent glioblastoma multiforme (GBM).
The Phase I/II single-arm study explored the safety and efficacy of the localized therapies in 34 patients. The dual implantation of Gliadel Wafer and radioactive seeds was well-tolerated among patients and may contribute to longer survival than when surgery is coupled with either therapy alone. Additional controlled clinical trials will need to be conducted in order to confirm this finding and demonstrate a survival benefit in comparison to control.