Overview

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.