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

18 Years
70 Years
Open (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 Recurrent 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
recurrent malignant glioma in 212 patients.

Inclusion Criteria:

- 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(exclude
patients with little tumors near the resectable tumor even if investigators think
they are single lesions)

- No obvious important organ dysfunction: Blood routine: White blood cell (WBC) ≥
4.0×109/L, Absolute neutrophil count (ANC)≥ 1.5×109/L, Platelets≥ 100×109/L,
Hemoglobin≥ 90 g/L; 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:

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

- Concomitant with other life-threatening diseases and with life expectancy <3 months;

- Allergic to nitrosourea drugs;

- With history of intracranial radiotherapy or implant chemotherapy;

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

- 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:

12 months

Safety Issue:


Principal Investigator

Zhong P Chen, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sun Yat-sen University


China: Food and Drug Administration

Study ID:

LJ-Glioma 3.1.0 Version



Start Date:

June 2012

Completion Date:

December 2013

Related Keywords:

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