The purpose of the study is to determine the safety and efficacy of intracranially implanted Carmustine in the treatment of patients with 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
212
Carmustine Sustained Release Implant
Routine tumor resection surgery
Sun Yat-Sen University Cancer Center
Guangzhou, Guangzhou, China
RECRUITINGOverall Survival
Time frame: 12 months
Overall Survival Rate
Time frame: 12 months
Progress Free Survival Rate at 6 months
Time frame: 12 months
Tumor response rate
Time frame: 12 months
KPS Score
Time frame: 12 months
QOL Score
Time frame: 12 months
Safety of intracranially implanted carmustine after maximal tumor resection
Occurrence rate of adverse event and serious adverse event revealed by laboratory test outcomes including blood routine and chemistry as well as physical examination, vital signs including blood presure, temperature, respiratory rate , heart rate.
Time frame: 12 months
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