Phase 3 Study of Carmustine Sustained Release Implant (CASANT) to Treat Recurrent Malignant Glioma
Malignant gliomas recur mostly 2 cm within originated area. Local therapies therefore become
particular important. Gliadel wafer developed in the States and marketed in the developed
countries is an example of such treatments. The product in this study, Carmustine Sustained
Release Implant (CASANT), is similar to that of Gliadel wafer as for the API(Active
Pharmaceutical Ingredient), but different as for drug delivering system. As required, the
preliminary clinical studies were conducted in China. Based on the results of phase I/II ,
8-10 wafers containing given dose of BCNU will be administered intracranially in this phase
III to the tumor resected cavity to investigate the safety and efficacy in the treatment of
recurrent malignant glioma in 212 patients.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Zhong P Chen, M.D.
Sun Yat-sen University
China: Food and Drug Administration
LJ-Glioma 3.1.0 Version