Clinical Trial: Safety and Efficacy Study of Intracranially Implanted Carmustine to Treat Recurrent Malignant Glioma

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Phase 3 Study of Carmustine Sustained Release Implant (CASANT) to Treat Recurrent Malignant Glioma

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Shandong Lanjin Pharmaceuticals Co.,Ltd

Current Primary Outcome: Overall Survival [ Time Frame: 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 [ Time Frame: 12 months ]
    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.


Original Secondary Outcome: Same as current

Information By: Shandong Lanjin Pharmaceuticals Co.,Ltd

Dates:
Date Received: July 4, 2012
Date Started: June 2012
Date Completion: December 2013
Last Updated: July 8, 2012
Last Verified: July 2012