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

• Status: Unknown status
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shandong Lanjin Pharmaceuticals Co.,Ltd
• Treatments: Carmustine

Criteria

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.