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

Glioblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01656980
• Other study ID #: LJ-Glioma 3. 3.0 Version
• Status: Not yet recruiting
• Phase: Phase 3
• First received: August 1, 2012
• Last updated: August 2, 2012
• Start date: August 2012
• Est. completion date: December 2014

Study information

• Verified date: August 2012
• Source: Shandong Lanjin Pharmaceuticals Co.,Ltd
• Contact: Yan H Sun, M.D.
• Phone: +86-1360-1389-945
• Email: sunyanhui1109[@]yahoo.com.cn
• 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 primary 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 primary malignant glioma in 236 patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 236
• Est. completion date: December 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Carmustine
As Experimental group, subjects will accept specified wafers of carmustine in the cavity while gliomas maximally be resected.

Procedure:
• tumor resection surgery
For this group, subjects will accept routine tumor resection surgery and place no implant wafers.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital Affiliated to Capital Medical University	Beijing	Beijing

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		15 months	No
Secondary	Progress Free Survival		15 months	No
Secondary	Overall Survival Rate at 12 months		15 months	No
Secondary	Karnofsky Performance Status(KPS)		15 months	No
Secondary	Quality of Life(QOL)		15 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 pressure, temperature, respiratory rate , heart rate.	15 months	Yes

External Links

•   You will see subjects recruitment information when visiting above website.