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

Phase 3

• Conditions: Anaplastic Astrocytoma; Anaplastic Oligodendroglioma; Anaplastic Oligoastrocytoma; Glioblastoma
• Interventions: Drug: Carmustine; Procedure: tumor resection surgery

• Registration Number: NCT01656980
• Lead Sponsor: Shandong Lanjin Pharmaceuticals Co.,Ltd

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 P...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2012-08
• Study Start: 2012-08
• Study First Submitted: 2012-08-01
• Study First Submitted QC: 2012-08-02
• Last Update Submitted: 2012-08-02
• Study First Posted: 2012-08-03
• Last Update Posted: 2012-08-03
• Primary Completion: 2014-08
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 236

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carmustine Sustained Release Implant	Carmustine	For subjects in this group, they will accept intracranially implanted carmustine intraoperatively.
Tumor Resection Surgery	tumor resection surgery	For subjects in this control group, they accept no implants while gliomas maximally be resected.

Primary Outcome Measures

Name	Time	Method
Overall Survival	15 months

Secondary Outcome Measures

Name	Time	Method
Progress Free Survival	15 months
Overall Survival Rate at 12 months	15 months
Karnofsky Performance Status(KPS)	15 months
Quality of Life(QOL)	15 months
Safety of intracranially implanted carmustine after maximal tumor resection	15 months	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.

Trial Locations

Locations (1)

Beijing Tiantan Hospital Affiliated to Capital Medical University; 🇨🇳 Beijing, Beijing, China