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

Shandong Lanjin Pharmaceuticals

Status

Unknown

Conditions

Glioblastoma

Anaplastic Oligoastrocytoma

Anaplastic Oligodendroglioma

Anaplastic Astrocytoma

Treatments

Procedure: Surgery

Drug: Carmustine(BCNU)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01637753

LJ-Glioma 3.1.0 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 recurrent 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 recurrent malignant glioma in 212 patients.

Enrollment

212 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.