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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01637753
Other study ID # LJ-Glioma 3.1.0 Version
Secondary ID
Status Recruiting
Phase N/A
First received July 4, 2012
Last updated July 8, 2012
Start date June 2012
Est. completion date December 2013

Study information

Verified date July 2012
Source Shandong Lanjin Pharmaceuticals Co.,Ltd
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 212
Est. completion date December 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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.

Study Design

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


Intervention

Drug:
Carmustine(BCNU)
Carmustine Sustained Release Implant
Procedure:
Surgery
Routine tumor resection surgery

Locations

Country Name City State
China Sun Yat-Sen University Cancer Center Guangzhou Guangzhou

Sponsors (1)

Lead Sponsor Collaborator
Shandong Lanjin Pharmaceuticals Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Survival 12 months No
Secondary Overall Survival Rate 12 months No
Secondary Progress Free Survival Rate at 6 months 12 months No
Secondary Tumor response rate 12 months No
Secondary KPS Score 12 months No
Secondary QOL Score 12 months No
Secondary Safety of intracranially implanted carmustine after maximal tumor resection 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 presure, temperature, respiratory rate , heart rate. 12 months Yes
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