NCT01656980

Safety and Efficacy Study of Intracranially Implanted Carmustine to Treat Newly Diagnosed Malignant Glioma

Phase 3 Study of Carmustine Sustained Release Implant (CASANT) to Treat Newly Diagnosed Malignant Glioma

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 236 (estimated)
• Sponsor: Shandong Lanjin Pharmaceuticals Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Anaplastic Astrocytoma
• Anaplastic Oligodendroglioma
• Anaplastic Oligoastrocytoma
• Glioblastoma

Interventions

Type	Name	Description
DRUG	Carmustine	As Experimental group, subjects will accept specified wafers of carmustine in the cavity while gliomas maximally be resected.
PROCEDURE	tumor resection surgery	For this group, subjects will accept routine tumor resection surgery and place no implant wafers.

Timeline

• Start date: 2012-08-01
• Primary completion: 2014-08-01
• Completion: 2014-12-01
• First posted: 2012-08-03
• Last updated: 2012-08-03

Locations

1 site across 1 country: China