Clinical trial NCT01637753: Safety and Efficacy Study of Intracranially Implanted Carmustine to Treat Recurrent Malignant Glioma
Official title: Phase 3 Study of Carmustine Sustained Release Implant (CASANT) to Treat Recurrent Malignant Glioma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anaplastic Astrocytoma
Anaplastic Oligodendroglioma
Anaplastic Oligoastrocytoma
Glioblastoma
Lead sponsor: Shandong Lanjin Pharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2012-07-11
Enrollment: 212
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 recurrent 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 recurrent malignant glioma in 212 patients.

Eligibility criteria: 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 control;
* Investigators thought unsuitable for enrollment.

Primary outcomes:
measure: Overall Survival
timeFrame: 12 months
Secondary outcomes:
measure: Overall Survival Rate
timeFrame: 12 months
measure: Progress Free Survival Rate at 6 months
timeFrame: 12 months
measure: Tumor response rate
timeFrame: 12 months
measure: KPS Score
timeFrame: 12 months
measure: QOL Score
timeFrame: 12 months
measure: Safety of intracranially implanted carmustine after maximal tumor resection
timeFrame: 12 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center
state: Guangzhou
Study officials:
affiliation: Sun Yat-sen University
name: Zhong P Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: