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

Shandong Lanjin Pharmaceuticals

Status and phase: Unknown; Phase 3

Conditions: Glioblastoma; Anaplastic Oligoastrocytoma; Anaplastic Oligodendroglioma; Anaplastic Astrocytoma

Treatments: Procedure: tumor resection surgery; Drug: Carmustine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01656980

LJ-Glioma 3. 3.0 Version

Details and patient eligibility

About

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.

Full 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.

Enrollment: 236 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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236 participants in 2 patient groups

Carmustine Sustained Release Implant

Experimental group

Description:

For subjects in this group, they will accept intracranially implanted carmustine intraoperatively.

Treatment:

Drug: Carmustine

Tumor Resection Surgery

Sham Comparator group

Description:

For subjects in this control group, they accept no implants while gliomas maximally be resected.

Treatment:

Procedure: tumor resection surgery