Safety and Efficacy Study of Intracranially Implanted Carmustine to Treat Newly Diagnosed Malignant Glioma

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2012 by Shandong Lanjin Pharmaceuticals Co.,Ltd
Sponsor:
Information provided by (Responsible Party):
Shandong Lanjin Pharmaceuticals Co.,Ltd
ClinicalTrials.gov Identifier:
NCT01656980
First received: August 1, 2012
Last updated: August 2, 2012
Last verified: August 2012

August 1, 2012
August 2, 2012
August 2012
August 2014   (final data collection date for primary outcome measure)
Overall Survival [ Time Frame: 15 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01656980 on ClinicalTrials.gov Archive Site
  • Progress Free Survival [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  • Overall Survival Rate at 12 months [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  • Karnofsky Performance Status(KPS) [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  • Quality of Life(QOL) [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  • Safety of intracranially implanted carmustine after maximal tumor resection [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]
    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 pressure, temperature, respiratory rate , heart rate.
Same as current
Not Provided
Not Provided
 
Safety and Efficacy Study of Intracranially Implanted Carmustine to Treat Newly Diagnosed Malignant Glioma
Phase 3 Study of Carmustine Sustained Release Implant (CASANT) to Treat Newly Diagnosed Malignant Glioma

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Anaplastic Astrocytoma
  • Anaplastic Oligodendroglioma
  • Anaplastic Oligoastrocytoma
  • Glioblastoma
  • Drug: Carmustine
    As Experimental group, subjects will accept specified wafers of carmustine in the cavity while gliomas maximally be resected.
    Other Names:
    • Trade name: CASANT
    • Other name: BCNU
  • Procedure: tumor resection surgery
    For this group, subjects will accept routine tumor resection surgery and place no implant wafers.
    Other Name: blank control group
  • Experimental: Carmustine Sustained Release Implant
    For subjects in this group, they will accept intracranially implanted carmustine intraoperatively.
    Intervention: Drug: Carmustine
  • Sham Comparator: Tumor Resection Surgery
    For subjects in this control group, they accept no implants while gliomas maximally be resected.
    Intervention: Procedure: tumor resection surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
236
December 2014
August 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact: Yan H Sun, M.D. +86-1360-1389-945 sunyanhui1109@yahoo.com.cn
Contact: Jian J Yu, Master +86-15336402751 yujj@lanjin.cn
China
 
NCT01656980
LJ-Glioma 3. 3.0 Version
Yes
Shandong Lanjin Pharmaceuticals Co.,Ltd
Shandong Lanjin Pharmaceuticals Co.,Ltd
Not Provided
Principal Investigator: Yan H Sun, M.D. Beijing Tiantan Hospital
Shandong Lanjin Pharmaceuticals Co.,Ltd
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP