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

• Status: Unknown status
• Trial end date: 2013-12-01
• 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 recurrent malignant glioma.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• 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(exclude patients with little tumors near the resectable tumor even if investigators think they are single lesions)

• No obvious important organ dysfunction: Blood routine: White blood cell (WBC) ≥ 4.0×109/L, Absolute neutrophil count (ANC)≥ 1.5×109/L, Platelets≥ 100×109/L, Hemoglobin≥ 90 g/L; 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:

• Tumor located at ventricular system, Open ventricle tumor cavity postoperatively;

• Concomitant with other life-threatening diseases and with life expectancy <3 months;

• Allergic to nitrosourea drugs;

• With history of intracranial radiotherapy or implant chemotherapy;

• With serious cardiac, pulmonary, hepatic and renal dysfunction, poor glycemic control;

• Investigators thought unsuitable for enrollment.