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

Phase 3
18 Years
70 Years
Not Enrolling
Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Anaplastic Oligoastrocytoma, Glioblastoma

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Trial Information

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

Inclusion Criteria:

- Confirmation of high grade glioma(WHO III or above)by frozen or squash preparation;

- Patients must be 18 to 70 years old, signed ICF;

- At least 4 weeks after previous chemotherapy (6 weeks since nitrosoureas);

- KPS ≥ 60;

- Unilateral, Supratentorial, solitary lesion and not crossing the midline

- No obvious important organ dysfunction: Hepatic function:Serum total bilirubin ≤1.5
times upper limit of laboratory normal; Aspartate aminotransferase (AST) and/or
Alanine aminotransferase (ALT)<2.5 times upper limit of laboratory normal; Renal
function:Serum creatinine ≤1.5 times upper limit of laboratory normal;

- Not Pregnant or lactating for women of childbearing potential.

Exclusion Criteria:

- Underwent cytoreductive surgery(excluded stereotactic biopsy);

- With chemotherapy or brain radiotherapy history;

- Tumor located at ventricular system, Open ventricle tumor cavity postoperatively;

- Concomitant with other life-threatening diseases and with life expectancy <12 months;

- Allergic to nitrosourea drugs;

- With history of intracranial radiotherapy or implant chemotherapy;

- With serious cardiac, pulmonary, hepatic and renal dysfunction, poor glycemic

- Experienced > 3 times of Large epilepsy within one month preoperatively.

- Investigators thought unsuitable for enrollment.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Time Frame:

15 months

Safety Issue:


Principal Investigator

Yan H Sun, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beijing Tiantan Hospital affiliated to Capital Medical University


China: Food and Drug Administration

Study ID:

LJ-Glioma 3. 3.0 Version



Start Date:

August 2012

Completion Date:

December 2014

Related Keywords:

  • Anaplastic Astrocytoma
  • Anaplastic Oligodendroglioma
  • Anaplastic Oligoastrocytoma
  • Glioblastoma
  • Astrocytoma
  • Glioblastoma
  • Oligodendroglioma
  • Glioma