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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Phase 3 Study of Carmustine Sustained Release Implant (CASANT) to Treat Newly Diagnosed 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 primary 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 primary malignant glioma in 236 patients.
Sponsor: Shandong Lanjin Pharmaceuticals Co.,Ltd

Current Primary Outcome: Overall Survival [ Time Frame: 15 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 [ Time Frame: 15 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 pressure, temperature, respiratory rate , heart rate.


Original Secondary Outcome:

  • Progress Free Survival [ Time Frame: 15 months ]
  • Overall Survival Rate at 12 months [ Time Frame: 15 months ]
  • KPS Score [ Time Frame: 15 months ]
  • QOL score [ Time Frame: 15 months ]
  • Safety of intracranially implanted carmustine after maximal tumor resection [ Time Frame: 15 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 pressure, temperature, respiratory rate , heart rate.


Information By: Shandong Lanjin Pharmaceuticals Co.,Ltd

Dates:
Date Received: August 1, 2012
Date Started: August 2012
Date Completion: December 2014
Last Updated: August 2, 2012
Last Verified: August 2012