Anaplastic Astrocytoma, Anaplastic Oligoastrocytoma, Anaplastic Oligodendroglioma, Glioblastoma
Conditions
Brief 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.
Detailed 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.
Interventions
DRUGCarmustine(BCNU)
Carmustine Sustained Release Implant
PROCEDURESurgery
Routine tumor resection surgery
Sponsors
Shandong Lanjin Pharmaceuticals Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progress Free Survival Rate at 6 months | 12 months | — |
| Tumor response rate | 12 months | — |
| Overall Survival Rate | 12 months | — |
| QOL Score | 12 months | — |
| Safety of intracranially implanted carmustine after maximal tumor resection | 12 months | Occurrence rate of adverse event and serious adverse event revealed by laboratory test outcomes including blood routine and chemistry as well as physical examination, vital signs including blood presure, temperature, respiratory rate , heart rate. |
| KPS Score | 12 months | — |
Countries
China
Outcome results
None listed