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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase 3 Study of Carmustine Sustained Release Implant (CASANT) to Treat Recurrent Malignant Glioma

Conditions
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Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Anaplastic Oligoastrocytoma, Glioblastoma

Intervention / Treatment
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* Drug: Carmustine(BCNU)
* Procedure: Surgery


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carmustine Sustained Release Implant<br> | Drug: Carmustine(BCNU)<br>* Carmustine Sustained Release Implant<br>* Other names: BCNU;|
| Sham Comparator: Surgical control group<br> | Procedure: Surgery<br>* Routine tumor resection surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival Rate |  | 12 months | 
| Progress Free Survival Rate at 6 months |  | 12 months | 
| Tumor response rate |  | 12 months | 
| KPS Score |  | 12 months | 
| QOL Score |  | 12 months | 
| Safety of intracranially implanted carmustine after maximal tumor resection | 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. | 12 months |