The purpose of the study is to determine the safety and efficacy of intracranially implanted Carmustine in the treatment of patients with primary 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 primary malignant glioma in 236 patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
236
As Experimental group, subjects will accept specified wafers of carmustine in the cavity while gliomas maximally be resected.
For this group, subjects will accept routine tumor resection surgery and place no implant wafers.
Beijing Tiantan Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China
Overall Survival
Time frame: 15 months
Progress Free Survival
Time frame: 15 months
Overall Survival Rate at 12 months
Time frame: 15 months
Karnofsky Performance Status(KPS)
Time frame: 15 months
Quality of Life(QOL)
Time frame: 15 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 pressure, temperature, respiratory rate , heart rate.
Time frame: 15 months
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