Clinical trial NCT01656980: Safety and Efficacy Study of Intracranially Implanted Carmustine to Treat Newly Diagnosed Malignant Glioma
Official title: Phase 3 Study of Carmustine Sustained Release Implant (CASANT) to Treat Newly Diagnosed Malignant Glioma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Anaplastic Astrocytoma
Anaplastic Oligodendroglioma
Anaplastic Oligoastrocytoma
Glioblastoma
Lead sponsor: Shandong Lanjin Pharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2012-08-03
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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 control;
* Experienced \> 3 times of Large epilepsy within one month preoperatively.
* Investigators thought unsuitable for enrollment.

Primary outcomes:
measure: Overall Survival
timeFrame: 15 months
Secondary outcomes:
measure: Progress Free Survival
timeFrame: 15 months
measure: Overall Survival Rate at 12 months
timeFrame: 15 months
measure: Karnofsky Performance Status(KPS)
timeFrame: 15 months
measure: Quality of Life(QOL)
timeFrame: 15 months
measure: Safety of intracranially implanted carmustine after maximal tumor resection
timeFrame: 15 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital Affiliated to Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Yan H Sun, M.D.
role: PRINCIPAL_INVESTIGATOR
References: